Trabecular Metal® 00-4349-012-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889024268951), received between Apr 1, 2020 and Jan 6, 2026 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026No Apparent Adverse Event

  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 23975013 ↗
• InjuryOct 24, 2025Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER ON AN APPROXIMATELY FOUR (4) YEARS AND SEVEN (7) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY ONE (1) YEAR AND FIVE (5) YEARS AGO DUE TO INCREASED PAIN AND LOSS OF RANGE OF MOTION DUE TO THE IMPLANT DISASSOCIATING WITH CLAVICULAR NONUNION AND SCAPULAR MALALIGNMENT.

  Patient problems: Bone Fracture(s); Bone Notching; Joint Dislocation; Loss of Range of Motion; Muscle Weakness/Atrophy; Nonunion/Delayed-union Bone Fracture; Osteolysis; Pain; Unequal Limb Length

  MAUDE report 23378391 ↗
• InjuryJun 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO DISASSOCIATION OF THE POLY AND STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 22175556 ↗
• InjuryOct 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO METALLOSIS, DISLOCATION, AS WELL AS STEM/LINER DISASSOCIATION. THE GLENOSPHERE WAS REPLACED, AS WELL AS THE POLY LINER. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

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

  MAUDE report 20410711 ↗
• InjuryNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PREVIOUSLY REPORTED REVERSE ARTHROPLASTY REVISION SURGERY ONE (1) YEAR AND TEN (10) MONTHS AGO DUE TO THE POLY COMPONENT DISASSOCIATING FROM THE STEM. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY ONE (1) WEEK AGO DUE TO THE POLY COMPONENT DISASSOCIATING FROM THE STEM AND PARTIAL SUBLUXATION. THE POLY WAS REMOVED AND REPLACED WITH A SPACER AND A RETENTIVE LINER. NO OTHER PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Osteopenia/ Osteoporosis; Subluxation

  MAUDE report 18118653 ↗
• MalfunctionJun 29, 2023Difficult 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 17228067 ↗
• InjuryJan 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED LOOSENING MENTIONED IN THE COMPLAINT DESCRIPTION WAS REFERENCING THE BASEPLATE, NOT THE STEM. THE BASEPLATE WILL BE REPORTED UNDER 0001822565-2023-01188.

  Patient problems: Failure of Implant

  MAUDE report 16196873 ↗
• 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 15433031 ↗
• InjurySep 14, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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: Failure of Implant; Muscle Hypotonia; Pain

  MAUDE report 15422285 ↗
• 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 15419049 ↗
• 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 15418824 ↗
• MalfunctionFeb 2, 2022Material Deformation; Material Deformation

  NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13426798 ↗
• InjuryJan 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant

  MAUDE report 13368745 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain; Swelling; Thrombus

  MAUDE report 9912562 ↗

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-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-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
• 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-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-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.