Trabecular Metal® 00-4349-030-02Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Trabecular Metal (74)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024269040), received between Sep 5, 2024 and Jan 27, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K121543, K130661); they may or may not involve this specific model.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Aseptic loosening1
- Erosion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2026Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening
MAUDE report 24188481 ↗InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY ON AND UNKNOWN DATE. THE PATIENT UNDERWENT THEIR FIRST REVISION APPROXIMATELY NINE (9) MONTHS AGO DUE TO AND UNKNOWN REASON. THEY THEN UNDERWENT A SECOND REVISION APPROXIMATELY (2) MONTHS AGO DUE TO AN UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A THIRD REVISION SURGERY DUE TO BONE LOSS.
Patient problems: Erosion
MAUDE report 20145121 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121543, K130661. One submission often covers many models, so check the product and lot details in each record.
- Z-0299-2020 · Oct 10, 2019 · TerminatedTrabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211
- Z-0609-2014 · Dec 10, 2013 · TerminatedTrabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page