VerSys® 8018-36-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024144736), received between Nov 16, 2020 and Nov 10, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

15 other recalls cover devices cleared under the same FDA submission (K953337); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: Aseptic loosening

  MAUDE report 23509973 ↗
• InjuryApr 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP SURGERY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED TWO YEARS POST IMPLANTATION DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 21893719 ↗
• InjuryOct 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 4 AND A HALF YEARS POST IMPLANTATION DUE TO DISLOCATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 20466566 ↗
• InjuryJan 23, 2024Material Erosion; Device Dislodged or Dislocated; Material Erosion; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO THE DEVELOPMENT OF PAIN, LIMB LENGTH DISCREPANCY, INSTABILITY WITH RECURRENT DISLOCATIONS, AND METALLOSIS. DURING THE PROCEDURE LARGE GRAY-BLACK SYNOVIAL EFFUSION, EXTENSIVE OSTEOLYSIS AND NECROTIC LESION OF R HIP SOFT TISSUE WITH COMPLETE LOSS OF HIP ABDUCTOR ATTACHMENTS ON PROXIMAL FEMUR NOTED. THERE WAS EXTENSIVE DEBRIDEMENT OF R HIP PSEUDOTUMOR. GROSS BLACK DEBRIS AROUND THE FEMORAL TRUNNION, THE PATIENT UNDERWENT REVISION, THE HEAD AND LINER COMPONENTS WERE EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Joint effusion; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Osteolysis; Pain; Unequal Limb Length

  MAUDE report 18562108 ↗
• InjuryAug 21, 2023Material Erosion; Naturally Worn; Material Erosion; Naturally Worn

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

  Patient problems: High metal ion levels; Metal Related Pathology

  MAUDE report 17584398 ↗
• InjuryJun 16, 2023Material Erosion; Device Dislodged or Dislocated; Material Erosion; Device Dislodged or Dislocated

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation; Metal Related Pathology; Osteopenia/ Osteoporosis; Pain

  MAUDE report 17143468 ↗
• InjuryApr 15, 2021Material Erosion; Material Erosion

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

  Patient problems: Fluid Discharge

  MAUDE report 11671558 ↗
• InjuryNov 16, 2020Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 10844667 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K953337. One submission often covers many models, so check the product and lot details in each record.

• 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-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-2581-2017 · Feb 28, 2017 · Terminated
  Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
• 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-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-1031-2014 · Oct 11, 2013 · Terminated
  12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
• Z-1034-2014 · Oct 11, 2013 · Terminated
  6 DEGREE COCR FEM HEAD 36
• Z-0070-2014 · Aug 30, 2013 · Terminated
  Versys Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160
• Z-2291-2010 · Jul 5, 2010 · Terminated
  VERSYS HIP SYSTEM FEMORAL HEAD 12/14 TAPER 28 MM DIA. -3.5 MM NECK LENGTH ZIMALOY CO-CR-MO ALLOY STERILE QTY-1 MANUFACTURED BY ZIMMER MANUFACTURING B.V., A SUBSIDIARY OF ZIMMER, IN
• Z-2290-2010 · Jul 5, 2010 · Terminated
  VERSYS HIP SYSTEM FEMORAL HEAD 12/14 TAPER 32 MM DIA. -3.5 MM NECK LENGTH ZIMALOY CO-CR-MO ALLOY STERILE QTY-1 MANUFACTURED BY ZIMMER MANUFACTURING B.V., A SUBSIDIARY OF ZIMMER, IN
• Z-0198-2010 · Aug 3, 2009 · Terminated
  Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw, IN; REF 8018-28-02. Intended for mating femoral stems equipped with tap
• Z-1066-05 · Apr 15, 2005 · Terminated
  Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Product 00-8018-032-02.