Trabecular Metal® 00-4349-036-03 (UDI 00889024633063)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024633063), received between Sep 15, 2022 and Dec 18, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846211 ↗
• InjuryMay 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY SEVEN (7) WEEKS AGO. SUBSEQUENTLY, THE PATIENT DEVELOPED SYMPTOMS OF INSTABILITY AND COULD POP THE SHOULDER JOINT IN AND OUT OF PLACE WITH LITTLE PAIN. THE PATIENT UNDERWENT A REVISION OF ALL PRODUCTS EXCEPT THE HUMERAL STEM APPROXIMATELY FOUR (4) WEEKS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 22012446 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RADIOGRAPHIC IMAGING, APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY AND A STRESS FRACTURE OF THE GREATER TUBEROSITY STEM WAS DISCOVERED ON IMAGING. THE PATIENT WAS PRESCRIBED TYLENOL THREE. APPROXIMATELY SIX (6) MONTHS AFTER THE FRACTURE WAS DISCOVERED, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION SURGERY DUE TO ACUTE ONSET OF PAIN AND INCREASED DIFFICULTY PERFORMING DAILY ACTIVITIES. THE POLY WAS REVISED AND A PECTORALIS MAJOR REPAIR WAS PERFORMED. THE SURGEON NOTED THE PATIENT DISPLAYED MUSCLE ATROPHY TO SURROUNDING TISSUES. NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: Bone Fracture(s); Muscle Hypotonia; Muscle/Tendon Damage; Pain

  MAUDE report 15433042 ↗

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-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-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-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-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-1418-06 · Jul 20, 2006 · Terminated
  Zimmer Trabecular Metal Reverse Shoulder System Base Plate; Catalog/Ref No. 00-4349-038-00.
• 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.