Trabecular Metal® 00-4349-036-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024269088), received between Apr 15, 2021 and Jan 6, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 reports).

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

Most reported problems

Recent adverse event reports

The 17 most recent of 17 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. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT DUE TO PAIN WITH ONSET ON AN UNKNOWN DAY, WITH INCONSISTENT RETURNS TO THE PHYSICIAN. IMAGING APPARENTLY SHOW THAT THE PATIENT IS EXPERIENCING SCAPULAR NOTCHING. THE PATIENT HAS NOT BEEN SCHEDULED FOR A REVISION, AND DUE TO HER PAST MEDICAL HISTORY MAY NOT GET CLEARED FOR ANOTHER PROCEDURE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Notching; Insufficient Information; Pain

  MAUDE report 23975104 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 23653233 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Discomfort; Pain

  MAUDE report 23575115 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) YEARS AND SIX (6) MONTHS AGO. SUBSEQUENTLY, THE PATIENT RECEIVED THREE SEPARATE CORTISONE INJECTIONS DUE TO PAIN AND SIGNS OF TENDONITIS. THE EVENT WAS REPORTED TO BE RESOLVED APPROXIMATELY ONE (1) YEAR AND THREE (3) MONTHS AGO.

  Patient problems: Extraskeletal ossification; Pain; Tendinopathy

  MAUDE report 23099854 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, 10 MONTHS POST-IMPLANTATION IT WAS REPORTED THAT THE PATIENT EXPERIENCES STIFFNESS WITH ROM AND SIGNIFICANT DELTOID WEAKNESS. THE PATIENT RECEIVED A CORTISONE INJECTION AND ADDITIONAL PHYSICAL THERAPY THAT FOCUSED ON ANTERIOR DELTOID STRENGTHENING APPROXIMATELY TWO MONTHS POST-IMPLANTATION. THE PATIENT NOTED NO FURTHER COMPLICATIONS AND THE ADVERSE EVENTS RESOLVED.

  Patient problems: Discomfort; Loss of Range of Motion

  MAUDE report 22738267 ↗
• InjuryMay 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY, SIX (6) YEARS AND NINE (9) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN AND DISLOCATION OF THE IMPLANTS.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 22046826 ↗
• InjuryJan 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 21066452 ↗
• InjurySep 16, 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 AN INITIAL REVISION SURGERY APPROXIMATELY NINE (9) YEARS AND FOUR (4) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT THE SECOND-STAGE OF A TWO STAGE REVISION SURGERY APPROXIMATELY SIX (6) MONTHS AGO DUE TO BONE LOSS.

  Patient problems: Insufficient Information

  MAUDE report 20228472 ↗
• InjuryJun 24, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 19593858 ↗
• InjuryMay 23, 2024Material Erosion; Device Dislodged or Dislocated; Material Erosion; 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.ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 19384700 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE NERVE PAIN CAUSED BY THE SUPERIOR SCREW BEING TOO LONG. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 18212883 ↗
• 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 THIRD REVISION SURGERY OF THEIR SHOULDER APPROXIMATELY SIX (6) YEARS AND THREE (3) MONTH AFTER THEIR SECOND REVISION SURGERY. THE PATIENT WAS REVISED DUE TO PAIN, RADIOLUCENCY, AND LOOSENING. THE PATIENT CONTINUES TO DISPLAY ATROPHY OF THE SURROUNDING MUSCLES. THERE WERE NO OTHER ADDITIONAL COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: Muscle Hypotonia; Pain

  MAUDE report 15422351 ↗
• 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 15419083 ↗
• 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 15418841 ↗
• InjuryMay 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY FIVE (5) YEARS AND SIX (6) MONTHS POST-IMPLANTATION DUE TO DISLOCATION. SURGEON IS CONSIDERING THE CAUSE FOR DISLOCATION WAS POSSIBLY OVER TENSION. PATIENT CURRENTLY HAS A SPACER MOLD IMPLANTED WHILE WAITING FOR A PMI DEVICE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; Osteopenia/ Osteoporosis

  MAUDE report 14307193 ↗
• InjuryOct 25, 2021Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

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

  Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 12693474 ↗
• InjuryApr 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation; Loss of Range of Motion

  MAUDE report 11672680 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052906, K121543, 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-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-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-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-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.
• Z-1416-06 · Jul 20, 2006 · Terminated
  Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 36 mm diameter; Catalog/Ref No. 00-4349-036-01.