Continuum® Trabecular Metal™ 00-8757-050-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024151345), received between Oct 21, 2021 and Dec 13, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K091508, K151448); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT. SUBSEQUENTLY, THE PATIENT HAD A FALL, LANDING ON THE HIP THAT WAS REPLACED, CAUSING THE DISLOCATION. THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 MONTH POST IMPLANTATION. PERIOPERATIVELY, THE SURGEON DECIDED TO EXCHANGE THE SHELL DUE TO SHELL MALPOSITION AND THE LINER FOR AN ELEVATED LINER. ON REMOVAL OF THE FEMORAL HEAD, THE STEM WAS REMOVED AND EXCHANGED FOR THE SAME OFFSET AND SIZE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 18317682 ↗
• MalfunctionAug 31, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE. DURING THE PROCEDURE, THE CONSTRAINED LINER WAS NOT PROPERLY INSERTED, AND THE SURGEON TAPPED IT FORCEFULLY, CAUSING THE LINER TO DIG INTO THE SHELL. THE LINER WAS REMOVED WITH THE SHELL BECAUSE IT WAS NO LONGER REMOVABLE. THE SURGERY WAS COMPLETED WITH A NEW SHELL AND CONSTRAINED LINER. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660559 ↗
• MalfunctionDec 29, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THE LINER WOULD NOT FULLY SEAT WITH THE CUP. THE PATIENT'S BONE QUALITY WAS TOO POOR; THEREFORE, THE SURGERY WAS COMPLETED WITH BIPOLAR DEVICES. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067920 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Inflammation; Pain

  MAUDE report 12671459 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091508, K151448. One submission often covers many models, so check the product and lot details in each record.

• Z-0094-2015 · Oct 1, 2014 · Terminated
  Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer
• Z-0072-2011 · Mar 19, 2010 · Terminated
  Continuum Acetabular Systems Shell Inserter Adapter without Rotational Control, 00-8790-003-10, Zimmer Inc., Warsaw, IN. Used to mate the inserter with the shell implant.
• Z-0071-2011 · Mar 19, 2010 · Terminated
  Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control, 00-8790-003-00, Zimmer Inc., Warsaw, IN. Used to mate the inserter with the shell implant.