Trabecular Metal® 00-4349-015-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024268999), received between Nov 1, 2019 and Jul 1, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 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 ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DAY DUE TO PAIN. IT APPEARS FROM IMAGING THAT THE PATIENT HAS MODERATE 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; Pain

  MAUDE report 25678909 ↗
• InjuryApr 18, 2025Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY SEVEN YEARS BACK. THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT DUE TO PAIN AND LOOSENING. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE AND NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21864457 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

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

  Patient problems: Erosion

  MAUDE report 16375247 ↗
• InjuryJun 29, 2022Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY FIVE (5) YEARS AND SEVEN (7) MONTHS POST-IMPLANTATION DUE TO DISLOCATION. SURGEON NOTED POSSIBLE CAUSE FOR DISLOCATION WAS OVER TENSION. X-RAYS WERE RECEIVED AND REVIEWED BY RADIOLOGIST NOTED BASEPLATE HAD LOOSENED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation; Osteopenia/ Osteoporosis

  MAUDE report 14859099 ↗
• InjuryOct 8, 2021Fracture; Unstable; Failure to Osseointegrate; Migration; Fracture; Unstable; Failure to Osseointegrate; Migration

  IT WAS REPORTED PATIENT UNDERWENT INITIAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO POSSIBLE INSTABILITY, DISASSOCIATION, IMPLANT FRACTURE AND IMPROPER INTEGRATION. DURING THE REMOVAL, IT WAS REPORTED THE GLENOID HAD LOOSENED OR WAS IMPROPERLY POSITIONED. WHEN THE SURGEON INSERTED THE HUMERAL PLATE, HE HAD TO USE A LOT OF TENSION AND STRENGTH. AS A RESULT, IT MAY HAVE HAPPENED THAT HE USED THE LEVERS TO PUSH THE GLENOSPHERE BACK OFF. THE BASE PLATE HAS ALSO BROKEN OUT. THERE WAS NO MENTION OF A TRAUMATIC EVENT. IN ADDITION, THE HUMERAL SHELL COULD NOT BE SEPARATED FROM THE SHAFT. CEMENT GOT INTO THE GAP BETWEEN THE SHAFT AND THE CONE. THE CEMENTED STEM WAS EXPLANTED WITH THE SHELL. ABNORMAL SPACING IS SEEN ON X-RAYS RECEIVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 12598881 ↗
• InjuryApr 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY APPROXIMATELY 5 MONTHS AGO. SUBSEQUENTLY, THE PATIENT HAD A REVISION DUE TO A DISLOCATED SHOULDER AND ISSUES WITH RANGE OF MOTION ABOUT 2 MONTHS AGO. DURING THE CASE, THE DOCTOR DECIDED TO EXPLANT THE TM REVERSE BASEPLATE AND IMPLANT THE COMPREHENSIVE REVERSE TO ACHIEVE DESIRED OUTCOME. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Joint Dislocation; Loss of Range of Motion

  MAUDE report 11672650 ↗
• MalfunctionNov 1, 2019Packaging Problem; Packaging Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 9265637 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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-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