Comprehensive® 110031407Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887868231391), received between May 25, 2022 and Sep 28, 2026 — classified as 3 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (4 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
- Tear, Rip or Hole in Device Packaging4
- Adverse Event Without Identified Device or Use Problem2
- Device Contaminated During Manufacture or Shipping2
- Device Dislodged or Dislocated1
- Manufacturing, Packaging or Shipping Problem1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information3
- Joint Dislocation1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Tear, Rip or Hole in Device Packaging
It was reported the box the implant was in was sealed, but the plastic bag it was in had a large tear in it. The event was identified during surgery, but the surgeon decided to implant it anyway after soaking it in beta-dine. It was reported that no further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916727 ↗MalfunctionSep 14, 2026Tear, Rip or Hole in Device Packaging
Patient problems: Insufficient Information
MAUDE report 50754585 ↗MalfunctionJan 23, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21218708 ↗MalfunctionJan 23, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21218686 ↗InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SHOULDER ARTHROPLASTY APPROXIMATELY TWO (2) MONTHS AGO DUE TO INSTABILITY. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION TO INCREASE CONSTRAINT ON AN UNKNOWN DATE. A CUSTOM IMPLANT REQUEST WAS SUBMITTED TO A COMPETITOR TO REPLACE ALL CURRENT IMPLANTS EXCEPT THE STEM AND GLENOID BASEPLATE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20515693 ↗InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SHOULDER ARTHROPLASTY APPROXIMATELY TWO (2) MONTHS AGO DUE TO INSTABILITY IN AN ATTEMPT TO INCREASE CONSTRAINT. THE HUMERAL TRAY AND BEARING WERE REPLACED 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 20515683 ↗MalfunctionMay 22, 2024Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19371152 ↗InjuryAug 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 17596584 ↗MalfunctionMay 25, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PACKAGING THAT THE IMPLANT WAS IN HAD A HOLE IN IT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14495911 ↗
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.