Trabecular Metal® 00-4349-036-03 (UDI 00889024269064)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024269064), received between Aug 20, 2021 and Jan 6, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

14 other recalls cover devices cleared under the same FDA submission (K052906, 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT-MATCHED IMPLANT (PMI) GROUP THAT A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DAY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Notching; Insufficient Information; Pain

  MAUDE report 23975074 ↗
• InjuryMar 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THAT A PATIENT WAS REVISED APPROXIMATELY 5 YEARS AGO DUE TO RECURRENT DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 21677824 ↗
• InjuryJun 5, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO METALLOSIS AND DISLOCATION. THE GLENOSPHERE WAS REPLACED, AS WELL AS THE POLY LINER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Dislocation; Metal Related Pathology

  MAUDE report 19473451 ↗
• InjuryJan 18, 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 16196874 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT REVERSE ARTHROPLASTY, SUBSEQUENTLY, APPROXIMATELY ONE (1) MONTH LATER THE PATIENT EXPERIENCED LEFT SIDED FACIAL DROOP, SLURRED SPEECH, AND ATAXIA DUE TO CEREBRAL VASCULAR ACCIDENT AND WAS ADMITTED TO THE HOSPITAL. PATIENT WAS PRESCRIBED A DAILY DOSE OF ASPIRIN AND THE EVENT WAS REPORTED TO BE RESOLVED TWO (2) DAYS LATER.

  Patient problems: Stroke/CVA

  MAUDE report 15419075 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY A MONTH AND A HALF AFTER THE SURGERY THE PATIENT REPORTED AN INCREASE OF PAIN DOWN THEIR ARM. THE PATIENT WAS DIAGNOSED WITH NERVE PAIN WITH NUMBNESS AND PRESCRIBED A MEDICATION (LYRICA 75MG). THE PATIENT IS SATISFIED AND ALL IMPLANT REMAIN IMPLANTED.

  Patient problems: Numbness; Pain

  MAUDE report 15418832 ↗
• InjuryMay 27, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE PATIENT'S FIRST REVISION SURGERY OF THEIR LEFT SHOULDER DUE TO DISASSOCIATION OF IMPLANTS. THE CAUSE OF THE DISASSOCIATION OF THE IMPLANTS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 14521748 ↗
• InjuryJan 18, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO DISLOCATION. WHEN THE REVISION TOOK PLACE, THE SURGEON NOTICED THE POLY LINER HAD BEEN BROKEN ON THE TAPER SIDE, AND WAS IN THE POSTERIOR OF THE SHOULDER JOINT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 13282999 ↗
• InjuryAug 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS POST IMPLANTATION, THE PATIENT WAS REVISED. THE PATIENT WAS NOTED TO HAVE AN ARM THAT WAS BECOMING ISCHEMIC. THE SURGEON HIGHLIGHTED THAT HE FELT THE CAUSE OF DISLOCATION WAS DUE TO POOR TUBEROSITY HEALING AND POOR DELTOID TENSIONING DUE TO PATIENT'S ANATOMY.

  Patient problems: Joint Dislocation

  MAUDE report 12347739 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052906, K130661. One submission often covers many models, so check the product and lot details in each record.

• Z-0299-2020 · Oct 10, 2019 · Terminated
  Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211
• Z-3144-2017 · May 22, 2017 · Terminated
  Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
• Z-0609-2014 · Dec 10, 2013 · Terminated
  Trabecular 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
• Z-1079-2014 · Oct 17, 2013 · Terminated
  Trabecular Metal" Reverse Shoulder System
• Z-2055-2013 · Aug 1, 2013 · Terminated
  00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate
• Z-0570-2011 · Sep 10, 2010 · Terminated
  ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems:
• Z-0571-2011 · Sep 10, 2010 · Terminated
  ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems
• Z-0576-2011 · Sep 10, 2010 · Terminated
  Zimmer Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number 97-4309-003-00, Rev. 4. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option
• Z-0575-2011 · Sep 10, 2010 · Terminated
  Zimmer Trabecular Metal Humeral Stem 4-Part Fracture Surgical Technique. Catalog Number 97-4309-004-00, Rev. 3. The Zimmer Trabecular Metal Shoulder System consists of convention
• Z-0573-2011 · Sep 10, 2010 · Terminated
  TRABECULAR METAL" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4312-
• Z-0574-2011 · Sep 10, 2010 · Terminated
  Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog Number: 97-4309-002-00, Rev. 3 The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, s
• Z-1416-06 · Jul 20, 2006 · Terminated
  Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 36 mm diameter; Catalog/Ref No. 00-4349-036-01.
• Z-1418-06 · Jul 20, 2006 · Terminated
  Zimmer Trabecular Metal Reverse Shoulder System Base Plate; Catalog/Ref No. 00-4349-038-00.
• Z-1417-06 · Jul 20, 2006 · Terminated
  Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 40 mm diameter; Catalog/Ref No. 00-4349-040-01.