As a sequel to the prior post (Section 1), here is a look at the literature on clinical results for the pyrocarbon shoulder implants. Results can be expressed as (a) revision rate and (b) patient-reported outcomes (PRO). At the outset we recognize that lack of a revision is not the same as a clinically significant improvement (i.e., improvement in PRO that exceeds the minimal clinically important difference, MCID). Lack of a revision may result from patient unwillingness to undergo another procedure, patient lost to follow-up, poor patient health, or patient death — none of which indicate a clinically significant improvement.
An issue confounding the available clinical results for pyrocarbon implants is that reports often combine legacy devices, revised versions, and current instantiations.
PYRO TYPE 1: PROXIMAL HUMERAL RESURFACING (PHR/PYROTITAN)
This implant has been through at least three significant design iterations and three commercial sponsors. None of the published papers isolates the current implant configuration. Every survivorship figure in the literature pools generations. The lineage, reconstructed from the McBride 2026 paper [1], the Hoy 2026 paper [2], the Therapeutic Goods Administration hazard alert [3], and contemporaneous trade press, is summarized in the following table.
The McBride 2026 registry cohort (n = 403, enrolled 2004–2022) spans all three iterations; and the reported 35%-of-revisions-from-breakage figure averages performance across known-fracture-prone implants and the current design.[1] The Hoy 2026 cohort (n = 119, enrolled January 2013–November 2023) starts at about the time of the TGA hazard alert; the earliest patients received the first-redesign implant; mid-cohort patients received the second-redesign implant, and late patients received the current implant.[2] Thus, the result for the current commercially available PHR/PyroTITAN implant is unknown. It cannot be extracted from the existing literature because every published series pools at least two device generations.
Here is what relates to the post-2017 third design:
Survivorship: cumulative percent revision (CPR) 7.7% at 10 yr (McBride 2026 [1]); 5-year Kaplan–Meier survivorship 97.5% (mean follow-up 34.6 months) (Hoy 2026 [2]). Manufacturer filings (not peer-reviewed): Kaplan–Meier survival ~86% up to ~117 mo as posted to ClinicalTrials.gov (NCT02405208 [9]). The primary endpoint of NCT02983292 [8] is device survival, not patient-reported outcomes; results are not yet published.
Effectiveness: WOOS 38→83 and ASES 49→87, all exceeding MCID (Hoy 2026 [2]).
PYRO TYPE 2: THE U.S. STEMMED PYROCARBON HEMIARTHROPLASTY (HA-PYC)
The FDA Investigational Device Exemption study [4] enrolled patients between December 2015 and April 2017, before the final round of design changes. The De Novo clearance was granted in 2022, and U.S. commercial use of the pyrocarbon humeral head began only in March 2023. The Griswold 2025 JBJS paper [5] reports the IDE patients at 5 years, not the post-clearance commercial cohort.
Survivorship: 3 of 157 revised before 24 mo, mean follow-up 24.4 mo; 3-year Kaplan–Meier revision-free survival 96.6% (Hatzidakis 2026 [4]). In the same IDE lineage followed forward (n = 45, mean follow-up 73 mo), 7-year revision-free survival 95.7% and failure-free survival 93.4% — the 2 revisions were both for infection (Griswold 2025 [5]).
Effectiveness: Composite Clinical Success 82.7%, defined as a ≥17-point Constant-score improvement without revision or device-related adverse event; ASES 44→88, adjusted Constant 51→91, SANE 36→85 (Hatzidakis 2026 [4]). At ≥5 years (mean 73 mo): ASES 47→96, SANE 39→94, Constant 48→88, all exceeding MCID, with glenoid morphology stable between the 2-year and final imaging (Griswold 2025 [5]).
PYRO TYPE 3: THE EUROPEAN STEMMED PYROCARBON HEMIARTHROPLASTY
The European cohort, followed a mean of 5.6 years [6], pools shoulders implanted before and after the systematic head-downsizing maneuver that became standard once Cointat reported that nonanatomic reconstruction (center of rotation > 3 mm off the anatomic center) occurred in 29% of cases and was strongly associated with glenoid erosion and revision [7].
With the current downsizing technique (Boileau 2026 [6]):
Survivorship: revision-free survival 94% at 5 yr and 89% at 10 yr.
Effectiveness: Constant 29→77, SSV 25%→84%, 91% return to work, 88% return to sport.
SUMMARY
Pyrocarbon shoulder arthroplasty is an exciting technology that is rapidly evolving. While evolution to address clinical issues (fracture, overstuffing, component malposition) is critical, it does confound the study of clinical outcomes: the implants on which follow-up data are available are often not the ones in current use. Once the designs and techniques have stabilized, data on revision rates and patient-reported outcomes for them will be of great interest.
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REFERENCES
1. McBride A, Hurley R, Gill D, Du P, Duke P, Taylor F, Hoy G, Page R, Ross M. Outcomes of pyrolytic carbon humeral resurfacing hemiarthroplasty compared to best-in-class total shoulder arthroplasty in young patients with osteoarthritis: analysis from the Australian Orthopaedic Association National Joint Replacement Registry. J Shoulder Elbow Surg. 2026;35(5):1209–1218. doi:10.1016/j.jse.2025.09.007.
2. Hoy G, Burrows K, McBride A, Ross M, Davis K, Warby S. PyroTITAN Pyrocarbon Shoulder Hemiarthroplasty: Clinical and Radiographic Outcomes with Medium-Term Follow-up. J Bone Joint Surg Am. Epub 2026 May 13. doi:10.2106/JBJS.25.00779.
3. Therapeutic Goods Administration. PyroTitan humeral resurfacing arthroplasty — hazard alert. Canberra, Australia: Australian Government Department of Health; August 2013. Available at: https://www.tga.gov.au/safety/recalls-and-other-market-actions/market-actions/pyrotitan-humeral-resurfacing-arthroplasty (LMT Surgical, 3% worldwide implant breakage rate, sub-surface fractures identified).
4. Hatzidakis AM, Garrigues GE, Mauter LA, de Gast A, Venegoni MR, Yang Y, Johnston PS. Clinical Outcomes of Pyrocarbon Hemiarthroplasty: A Short-Term, Multicenter Study. J Bone Joint Surg Am. 2026;108(8):572–583. doi:10.2106/JBJS.25.00054.
5. Griswold BG, Berger JM, Davis BP, Mauter L, Boyd M, Schuette HB, Johnston PS, Sears BW, Hatzidakis AM. Five-Year Radiographic and Clinical Outcomes of Pyrocarbon Hemiarthroplasty for Glenohumeral Arthritis and Osteonecrosis. J Bone Joint Surg Am. 2025;107(24):2751–2762. doi:10.2106/JBJS.25.00163.
6. Boileau P, Cointat C, Raynier JL, Schippers P, Ranieri R. Pyrocarbon hemiarthroplasty for the treatment of shoulder osteoarthritis in young, active patients: survival and risk factors for revision. J Shoulder Elbow Surg. 2026;35(2):421–437. doi:10.1016/j.jse.2025.06.021.
7. Cointat C, Raynier JL, Vasseur H, Lareyre F, Raffort J, Gauci MO, Boileau P. Short-term outcomes and survival of pyrocarbon hemiarthroplasty in the young arthritic shoulder. J Shoulder Elbow Surg. 2022;31(1):113–122. doi:10.1016/j.jse.2021.06.002.
8. ClinicalTrials.gov. A Clinical and Radiological Study to Evaluate the Safety and Efficacy of the PyroTITAN Humeral Resurfacing Arthroplasty (HRA) Device in a New Cohort of Patients After Product Re-Release (T-HRA-003). NCT02983292. Sponsor: Smith & Nephew. Completed February 2023; results posted to ClinicalTrials.gov 2024 (not peer-reviewed). https://clinicaltrials.gov/study/NCT02983292.
9. ClinicalTrials.gov. A Multi-center Outcomes Clinical Study of the PyroTITAN HRA Shoulder Implant in Humeral Head Resurfacing (CP-HRA-002). NCT02405208. Sponsor: Smith & Nephew. Enrollment 156; completed September 2023; results posted to ClinicalTrials.gov 2025 (not peer-reviewed). https://clinicaltrials.gov/study/NCT02405208.