Trabecular Metal® 00-4349-040-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024269149), received between Jan 23, 2020 and May 6, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY TWO (2) YEARS AND FOUR (4) MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS LATER DUE TO DISLOCATION. THE PATIENT WAS FITTED WITH THICKER COMPONENTS TO STRENGTHEN COMPONENT CONNECTIONS DURING THE REVISION, AND NO OTHER HARMS WERE REPORTED DUE TO THIS EVENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 19255239 ↗
• InjuryMar 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AND INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY AND LEFT BICEPS TENODESIS DUE TO LEFT ROTATOR CUFF ARTHROPATHY AND BICEPS TEAR. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY SEVEN (7) WEEKS LATER DUE TO DISASSOCIATION OF IMPLANTS. PATIENT DENIES ANY TRAUMATIC EVENT THAT CAUSED THE IMPLANTS TO DISASSOCIATE.

  Patient problems: Failure of Implant

  MAUDE report 13889937 ↗
• InjuryApr 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL PROCEDURE APPROXIMATELY 1 YEAR AND 4 MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 MONTH POST-IMPLANTATION DUE TO PAIN AND DISCOMFORT. DURING SURGERY, IT WAS DISCOVERED THAT THE POLY HAD DISASSOCIATED FROM THE HUMERAL TRAY AND THE GLENOSPHERE WAS SEVERELY SCRATCHED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Discomfort; Pain; Scar Tissue

  MAUDE report 11671134 ↗
• MalfunctionJan 23, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A REVERSE SHOULDER REVISION WHILE INSERTING THE LINER, IT WAS PROPERLY LINED UP THE HUMERAL SPACER AND IMPACTED. HOWEVER, THE LINER WAS NOT SEATING PROPERLY, IT WAS NOT FLUSH AGAINST THE SPACER. THE SURGEON SHOWED THE GAP BY FITTING A THICK BLADE IN BETWEEN. THE SURGEON THEN ATTEMPTED TO IMPACT FURTHER AND STILL WAS NOT ABLE TO SEAT THE LINER FLUSH AGAINST THE SPACER. THE LINER WAS REMOVED AND A NEW LINER WAS IMPACTED, WHICH FULLY SEATED FLUSH AGAINST THE SPACER WITH NO GAP IN BETWEEN. NO IMPACT TO THE PATIENT OR SURGERY WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9622043 ↗

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-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-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-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-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-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-1416-06 · Jul 20, 2006 · Terminated
  Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 36 mm diameter; Catalog/Ref No. 00-4349-036-01.
• Z-1417-06 · Jul 20, 2006 · Terminated
  Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 40 mm diameter; Catalog/Ref No. 00-4349-040-01.
• Z-1418-06 · Jul 20, 2006 · Terminated
  Zimmer Trabecular Metal Reverse Shoulder System Base Plate; Catalog/Ref No. 00-4349-038-00.