Trabecular Metal® 00-4350-013-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024269323), received between Jun 23, 2020 and Jun 23, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K122692, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Joint Dislocation

  MAUDE report 10186922 ↗
• InjuryJun 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED PATIENT UNDERWENT A REVERSE SHOULDER ARTHROPLASTY APPROXIMATELY FIVE (5) MONTHS AGO. APPROXIMATELY ONE (1) MONTH POST IMPLANTATION, PATIENT UNDERWENT A REVISION DUE TO PAIN, DISLOCATION, AND THE POLY LINER DISENGAGING FROM THE STEM. SURGEON ONLY REMOVED AND REPLACED A NEW POLY LINER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 10186918 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122692, 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