Comprehensive® Reverse Shoulder 115400Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304677128), received between Nov 9, 2022 and Jan 27, 2026 — classified as 6 injuries, 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
- Failure to Osseointegrate1
- Improper or Incorrect Procedure or Method1
Patient problems
- Failure of Implant2
- Aseptic loosening1
- Foreign Body In Patient1
- Inadequate Osseointegration1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2026Fracture; Failure to Osseointegrate
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER: 0001825034-2026-00180.
Patient problems: Aseptic loosening
MAUDE report 24190646 ↗InjuryJan 21, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 24137333 ↗InjuryNov 11, 2024Adverse 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: Insufficient Information
MAUDE report 20651793 ↗InjuryOct 2, 2024Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20351832 ↗InjuryAug 31, 2023Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS IMPLANTING THE IMPLANT DURING A SHOULDER ARTHROPLASTY, THE IMPLANT FRACTURED. THE SURGEON WAS NOT ABLE TO REMOVE ALL OF THE IMPLANT AND THE PATIENT RETAINED A PORTION OF THE IMPLANT. THE SURGEON WAS ABLE TO IMPLANT A SECOND IMPLANT. THERE ARE NO PLANS TO REVISE THE PATIENT AND REMOVE THE PIECE OF THE IMPLANT THAT WAS RETAINED IN THE PATIENT'S BONE.
Patient problems: Foreign Body In Patient
MAUDE report 17663468 ↗InjuryJul 14, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND STAGE REVISION PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO FRACTURED SCREWS APPROXIMATELY FOUR (4) MONTHS POST-IMPLANTATION.
Patient problems: Failure of Implant
MAUDE report 17324309 ↗MalfunctionNov 9, 2022Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS IMPLANTING THE IMPLANT, IT FRACTURED. THE SURGEON WAS ABLE RETRIEVE THE PIECE OF THE IMPLANT AND A SHORTER IMPLANT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15761242 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.