Trabecular Metal® 00-4349-010-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024268937), received between Jun 16, 2021 and Oct 23, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

18 other recalls cover devices cleared under the same FDA submission (K052906, K060704, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A SHOULDER ARTHROPLASTY APPROXIMATELY 4 YEARS AGO. SUBSEQUENTLY THE PATIENT IS SUFFERING FROM SUFFICIENT AMOUNTS OF HETEROTOPIC OSSIFICATION OF THE JOINT CAPSULE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Extraskeletal ossification

  MAUDE report 17985825 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AFTER THE IMPLANTATION OF A PRIMARY SHOULDER APPROXIMATELY 6 MONTHS AGO. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 15347859 ↗
• InjuryJun 16, 2021Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 12011312 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052906, K060704, 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-2213-2012 · Jul 18, 2012 · Terminated
  00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65 Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropr
• Z-2215-2012 · Jul 18, 2012 · Terminated
  00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65 Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the approp
• Z-2212-2012 · Jul 18, 2012 · Terminated
  Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 6
• Z-2214-2012 · Jul 18, 2012 · Terminated
  00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriat
• 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-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-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-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-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-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

…and 3 more.