Comprehensive SRSRecalls & reported problems across all models
Biomet Orthopedics, LLC · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls
- 0
We found 22 models of Comprehensive SRS by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2020 and May 22, 2026 — classified as 42 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Comprehensive SRS problems
Device problems
- Adverse Event Without Identified Device or Use Problem26
- Detachment of Device or Device Component9
- Loosening of Implant Not Related to Bone-Ingrowth5
- Insufficient Device Problem Information2
- Migration2
- Inadequacy of Device Shape and/or Size1
- Loss of or Failure to Bond1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Pain21
- Failure of Implant8
- Insufficient Information8
- Implant Pain4
- Joint Dislocation4
- Adhesion(s)3
- Discomfort3
- Extraskeletal ossification2
Comprehensive SRS models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Comprehensive SRS 211228PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED8 reports
- Comprehensive® SRS 211230PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED3 reports
- Comprehensive® SRS 211256PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Comprehensive® SRS 211218PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED3 reports
- Comprehensive® SRS 211223PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED3 reports
- Comprehensive® SRS 211215PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Comprehensive® SRS 211224PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Comprehensive® SRS 211216PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED2 reports
- Comprehensive® SRS 211235PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED2 reports
- Comprehensive® SRS 211238PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- Comprehensive® SRS 211236PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Comprehensive® SRS 110029824PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Comprehensive® SRS 211237PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Comprehensive® SRS 211243PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Comprehensive® SRS 211239PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Comprehensive® SRS 211231PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Comprehensive® SRS 211244PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 report
- Comprehensive® SRS 211240PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Comprehensive® SRS 211226PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Comprehensive SRS 211229PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Comprehensive® SRS 211221PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Comprehensive® SRS 110029940PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
Recent Comprehensive SRS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INITIAL LEFT TOTAL HUMERAL ARTHROPLASTY WAS PERFORMED. THE PATIENT SUBSEQUENTLY DEVELOPED A WOUND-HEALING COMPLICATION. APPROXIMATELY TWO AND A HALF MONTHS AFTER THE INDEX PROCEDURE, DEBRIDEMENT OF SOFT TISSUE AND ANTIBIOTIC THERAPY WERE PERFORMED. ALL IMPLANTS REMAINED IMPLANTED. AT ONE-YEAR FOLLOW-UP, THE PATIENT REPORTED BEING SATISFIED. DUE DILIGENCE IS COMPLETE FOR THIS COMPLAINT; IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE, AND TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Post Operative Wound Infection
MAUDE report 25258099 ↗InjuryMar 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY FOUR WEEKS POST-IMPLANTATION DUE TO DETACHMENT OF THE MODULAR HEAD. THE PATIENT WAS EXPERIENCING PAIN PRIOR TO THE REVISION. THE HEAD AND BODY WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 24639386 ↗InjuryMar 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY FOUR WEEKS POST-IMPLANTATION DUE TO DETACHMENT OF THE MODULAR HEAD. THE PATIENT WAS EXPERIENCING PAIN PRIOR TO THE REVISION. THE HEAD AND BODY WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 24639380 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24532541 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS BEING CONSIDERED FOR A REVISION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 24532523 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 23660792 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 23660780 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 23660769 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 23660760 ↗InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Pain
MAUDE report 23575780 ↗InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Pain
MAUDE report 23575777 ↗InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Pain
MAUDE report 23574146 ↗InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Extraskeletal ossification; Pain; Tendinopathy
MAUDE report 23100079 ↗InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HAD A INITIAL LEFT REVERSE TOTAL SHOULDER. SUBSEQUENTLY, IT WAS REPORTED APPROXIMATELY 5 YEAR POST-IMPLANTATION THE PATIENT RECEIVED 3 SEPARATE CORTISONE INJECTIONS DUE TO PAIN AND SIGNS OF TENDONITIS. THE EVENT WAS REPORTED AS RESOLVED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Extraskeletal ossification; Pain; Tendinopathy
MAUDE report 23100073 ↗InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT ENTERED CLINICAL STUDY UPON REVISION OF RIGHT RTSA WITH REPAIR OF COMMUTED HUMERAL FRACTURE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ONGOING PAIN WITH NO IDENTIFIED IMPLANT ABNORMALITIES AND RECEIVED INJECTION APPROXIMATELY 4 YEARS POST-IMPLANTATION WITH RESOLUTION. REMAINS IMPLANTED AT STUDY COMPLETION.
Patient problems: Implant Pain; Pain
MAUDE report 22621111 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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