Comprehensive® Reverse Shoulder 115397Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00880304677098), received between Mar 16, 2020 and Oct 28, 2025 — classified as 16 injuries.
The most frequently reported specific device problem is “Fracture” (6 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture6
- Loosening of Implant Not Related to Bone-Ingrowth4
- Adverse Event Without Identified Device or Use Problem3
- Detachment of Device or Device Component1
- Inadequacy of Device Shape and/or Size1
- Insufficient Device Problem Information1
- Positioning Failure1
Patient problems
- Failure of Implant8
- Foreign Body In Patient3
- Insufficient Information3
- Pain3
- Bone Fracture(s)2
- Aseptic loosening1
- Fall1
- Joint Dislocation1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryOct 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening; Septic loosening; Unspecified Infection
MAUDE report 23405944 ↗InjuryApr 24, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS INSERTING THE IMPLANT, THE IMPLANT FRACTURED. THE SURGEON MADE THE DECISION TO LEAVE THE PART OF THE IMPLANT THAT FRACTURED IN THE PATIENT'S BONE INSIDE THE PATIENT AND DID NOT ATTEMPT TO REMOVE IT. THE PIECE DID NOT IMPACT THE SEATING OF THE GLENOSPHERE.
Patient problems: Foreign Body In Patient
MAUDE report 21904408 ↗InjuryMar 25, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Foreign Body In Patient; Joint Dislocation; Metal Related Pathology
MAUDE report 21690058 ↗InjuryMar 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 21612481 ↗InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS FURTHER REPORTED THAT THE PATIENT WAS GETTING DRESSED AND FELT A POPPING SENSATION WHICH LEAD TO THE REVISION PROCEDURE.
Patient problems: Bone Fracture(s)
MAUDE report 21504794 ↗InjuryJan 22, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21207307 ↗InjuryNov 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS FURTHER REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 13 MONTHS POST IMPLANTATION DUE TO GLENOID LOOSENING AND PAIN IN THE SHOULDER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 20708582 ↗InjuryOct 23, 2024Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY TWO AND A HALF YEARS (2.5) YEARS FOLLOWING SHOULDER ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION DUE TO FRACTURED BASEPLATE SCREWS. THE BASEPLATE, GLENOSPHERE, TRAY, BEARING, AND SCREWS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS. THE CASE WAS COMPLETED WITHOUT ANY REPORTED ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20515487 ↗InjuryOct 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Loss of Range of Motion; Pain
MAUDE report 20397710 ↗InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s)
MAUDE report 18970062 ↗InjuryJun 8, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY APPROXIMATELY THREE (3) YEARS AND NINE (9) MONTHS AGO. SUBSEQUENTLY, THE PATIENT FELL ON AN UNKNOWN DATE AND FRACTURED SCREWS WITHIN THE BASEPLATE. PATIENT WAS LATER REVISED APPROXIMATELY NINE (9) MONTHS AGO AND CONVERTED TO A HEMI-ARTHROPLASTY. DURING THE REVISION, IT WAS NOTED THREE OF THE FRACTURED SCREW SHAFTS COULD NOT BE REMOVED FROM THE BONE AND WERE RETAINED BY THE PATIENT. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Fall; Foreign Body In Patient
MAUDE report 17090546 ↗InjuryAug 12, 2022Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS A REVISION FOR GLENOSPHERE DISASSOCIATED DUE TO CENTRAL SCREW NOT BEING SEATED PROPERLY AT PRIMARY OPERATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15217907 ↗InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT IS EXPERIENCING SHOULDER PAIN, INSTABILITY, AND ROM ISSUES APPROXIMATELY SEVEN YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 15212155 ↗InjuryJun 28, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE (1) MONTH POST-IMPLANTATION DUE TO THE GLENOSPHERE DISASSOCIATING FROM THE MINI BASEPLATE. IT WAS NOTED DURING THE REVISION THAT THE LENGTH OF THE CENTRAL SCREW WAS ON THE SHORTER SIZE, SO THE SURGEON USED A LONGER SCREW INSTEAD. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 14841156 ↗InjuryApr 27, 2022Fracture; Fracture
IT WAS REPORTED A PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, HAD AN INCIDENT WHERE SHE PUT HER ARM IN A REACHING BACK POSITION AND FELT THE IMPLANT GIVE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 14218517 ↗InjuryMar 16, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULD ARTHROPLASTY. SUBSEQUENTLY, UNDERWENT A REVISION DUE TO LOOSENING OF THE IMPLANT. THE X-RAY PROVIDED SHOWS DISLOCATION OF THE SHOULDER. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 9835935 ↗
Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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