Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated health care system

Benchmarking allows for measurements and comparisons of prostheses using agreed-upon standards so that surgeons may be informed on performance for clinical decision making. We sought to apply the Orthopaedic Data Evaluation Panel (ODEP) for Shoulders methodology to benchmark prostheses used for shoulder arthroplasty in a US integrated health care system. Data from the Kaiser Permanente shoulder arthroplasty registry was used to identify 25,495 primary shoulder arthroplasties (2009-2024): 11,392 anatomic total shoulder arthroplasties (aTSAs), 1,204 elective hemiarthroplasties, 10,385 elective reverse total shoulder arthroplasties (rTSAs), 967 acute hemiarthroplasties, and 1,547 acute rTSAs. Cumulative percentage all-cause revision (CPR) and 95% confidence interval (CI) was calculated using 1 minus the Kaplan-Meier estimate. An A rating was given for implants where the upper bound of the 95% CI was less than 5.0%, 7.0%, 9.0%, or 12.0% at 3-, 5-, 7-, and 10-year follow-up; a B rating was where the lower bound of the 95% CI was less than 5.0%, 7.0%, 9.0%, or 12.0% at 3-, 5-, 7-, and 10-year follow-up, respectively. There were 16 and 21 unique glenoid and humeral stem components, respectively, that qualified for benchmarking, used in 95.1% and 94.6% of the aTSA cohort, respectively. Of the aTSA glenoid components, 8 received A ratings, 6 B ratings, and 2 failed to receive a benchmark; 13, 6, and 2 humeral stem components received A, B, or no ratings, respectively. Five hemiarthroplasty humeral stems received a B rating, whereas 3 received no benchmark. Thirty unique elective rTSA constructs were evaluated, used in 72.0% of procedures. Eleven, 12, and 7 of the elective rTSA constructs received A, B, or no ratings, respectively. Three acute hemiarthroplasty humeral stems received a B rating, and 3 received no benchmark. There were 8 unique rTSA constructs for fracture evaluated; 1 received an A rating whereas 7 received B ratings. We identified several prostheses that qualified for ratings using the ODEP benchmarking criteria. However, there was a larger proportion of prostheses used at too low a volume for benchmarking consideration. In terms of patients, 74.6% of the study sample received components and/or constructs receiving a rating, 10.3% received components and/or constructs that failed to receive a rating, and 15.1% of patients received components and/or constructs that did not meet the ODEP criteria for benchmarking. Registries are a valuable data source for postmarket evaluation of implant performance in a real-world setting that can be used to inform clinical, health care, and regulatory decision making on implant selection.