Comprehensive® 110031402Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887868231346), received between Jan 7, 2020 and Jul 31, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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
- Detachment of Device or Device Component8
- Device Dislodged or Dislocated1
- Noise, Audible1
- Unstable1
Patient problems
- Failure of Implant4
- Joint Dislocation3
- Bone Fracture(s)1
- Crepitus1
- Insufficient Information1
- Joint Laxity1
- No Information1
- Pain1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2026Detachment of Device or Device Component
It was reported that the patient underwent an initial implantation on an unknown date. Subsequently, the patient was revised approximately nineteen (19) months ago due to disassociation of the poly bearing from the tray. Attempts have been made and no further information has been provided.
Patient problems: Crepitus; Insufficient Information
MAUDE report 50096877 ↗InjuryNov 12, 2024Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY NINE (9) MONTHS AGO. THE PATIENT ON AND UNKNOWN DATE PRESENTED WITH A DISLOCATED SHOULDER THAT WAS REDUCED. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY ONE (1) MONTH AGO DUE TO INSTABILITY AND AN AUDIBLE CLUNK. THE SURGEON NOTED THAT THE BEARING HAD DISASSOCIATED FROM THE TRAY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 20664433 ↗InjuryJun 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 19523745 ↗InjuryAug 28, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 17632454 ↗InjuryMar 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16590093 ↗InjuryMay 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 11819853 ↗InjuryDec 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 11020442 ↗InjuryDec 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 11003418 ↗InjuryJan 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED PATIENT SUFFERED PAIN DUE TO DISASSOCIATED PROSTHESIS APPROXIMATELY ONE MONTH POST-IMPLANTATION. DUE TO SHORT NOTICE, REPLACEMENT IMPLANTS AND INSTRUMENTS WERE NOT AVAILABLE. THE SURGEON REATTACHED THE GLENOSPHERE AND HUMERAL BEARING TO BASEPLATE, USED 2 JUGGERKNOTS TO HELP STABILIZE THE SHOULDER. TWO CERCLAGE WIRES WERE ATTACHED TO SITE. PATIENT WILL BE OBSERVED TO SEE HOW HE DOES.. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Bone Fracture(s); No Information; Pain
MAUDE report 9558399 ↗
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.