Comprehensive® 110031404Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Comprehensive (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868231360), received between Jan 12, 2022 and Jan 23, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging3
- Detachment of Device or Device Component1
- Device Contaminated During Manufacture or Shipping1
- Device Damaged Prior to Use1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration or Expulsion of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Failure of Implant1
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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
IT WAS REPORTED THAT THE STERILE PACKAGING HAD HOLES IN IT AND THERE WAS PLASTIC DEBRIS IN THE PACKAGE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21218716 ↗MalfunctionMar 28, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT WHEN THE DEVICE PACKAGING WAS OPENED, IT WAS DAMAGED INSIDE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18995238 ↗MalfunctionMay 25, 2022Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE STERILE PACKAGING WAS WORN AND THE IMPLANT HAD A SMUDGE ON IT. SUBSEQUENTLY, THE SURGEON DID NOT USE THE IMPLANT AND ANOTHER IMPLANT WAS OPENED. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14496306 ↗InjuryJan 12, 2022Migration or Expulsion of Device; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Migration or Expulsion of Device; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REPLACEMENT SURGERY ON AN UNKNOWN DATE WITH COMPETITOR DEVICES AND SUBSEQUENTLY REVISED ON UNKNOWN DATE USING ZIMMER BIO MET PRODUCTS. AGAIN THE PATIENT WAS REVISED SECOND TIME LESS THAN TWO MONTHS LATER DUE TO LOOSENING OF THE HUMERAL TRAY. THE TRAY AND BEARING WERE REPLACED WITH NO ALLEGATIONS AGAINST THE BEARING.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 13238514 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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 14, 2026 · each report above links to its original FDA record
- 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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