VerSys® 7843-12-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024136502), received between Jun 21, 2022 and Jun 21, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K973714); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO IMPLANT FRACTURE APPROXIMATELY 16 YEARS POST IMPLANTATION. THE STEM, HEAD, SHELL, AND LINER WERE EXCHANGED AND COMPETITOR PRODUCT WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Metal Related Pathology; Pain

  MAUDE report 14759221 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K973714. One submission often covers many models, so check the product and lot details in each record.

• Z-1024-2018 · Nov 29, 2017 · Terminated
  VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• Z-1023-2018 · Nov 29, 2017 · Terminated
  VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• Z-1025-2018 · Nov 29, 2017 · Terminated
  VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• Z-1026-2018 · Nov 29, 2017 · Terminated
  VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• Z-1022-2018 · Nov 29, 2017 · Terminated
  VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
• Z-0722-2018 · Aug 1, 2017 · Terminated
  Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED F
• Z-0848-2016 · Jan 11, 2016 · Terminated
  VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheu
• Z-1842-2014 · May 19, 2014 · Terminated
  VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581