VerSys® 7843-13-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024136533), received between Jan 6, 2023 and Jun 19, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

22 other recalls cover devices cleared under the same FDA submission (K953337, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 7 WEEKS AFTER REVISION PROCEDURE, THE PATIENT PRESENTED WITH INCREASED PAIN AND ELEVATED INFLAMMATORY MARKERS. AFTER THE HEAD AND BEARING WERE EXCHANGED, THE INFECTION CONTINUED WITHOUT HEALING REQUIRING A FULL 2-STAGE REVISION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17157122 ↗
• InjuryJan 6, 2023Material Erosion; Insufficient Device Problem Information; Material Erosion; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT'S LEGAL COUNSEL THAT THE PATIENT HAD A VERSYS FEMORAL HEAD AND A ZIMMER M/L TAPER STEM IMPLANTED IN THE LEFT HIP. IT WAS REPORTED THAT THE LEFT HIP COMPONENTS WERE LATER EXPLANTED FOR ALLEGATIONS OF UNSPECIFIED INJURIES. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Insufficient Information; Metal Related Pathology; Osteopenia/ Osteoporosis; Pain

  MAUDE report 16115797 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K953337, 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-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-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-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-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-2581-2017 · Feb 28, 2017 · Terminated
  Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
• Z-2580-2017 · Feb 28, 2017 · Terminated
  Por fullct fem st 18x200mm, Sterile,
• Z-2578-2017 · Feb 28, 2017 · Terminated
  Por fullct fem st 16x200mm, Sterile,
• Z-2577-2017 · Feb 28, 2017 · Terminated
  Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- Specific Knee, Hip and Nail Implants
• Z-2579-2017 · Feb 28, 2017 · Terminated
  Por fullct fem st 17x200mm, Sterile,
• 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-0849-2016 · Jan 11, 2016 · Terminated
  VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Tota
• Z-1127-2016 · Jan 11, 2016 · Terminated
  Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL
• Z-1842-2014 · May 19, 2014 · Terminated
  VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581

…and 7 more.