VerSys® 8018-36-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889024144729), received between Jul 22, 2020 and Nov 18, 2025 — classified as 24 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581853 ↗
• InjuryNov 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 5 YEARS AND 5 MONTHS POST-IMPLANTATION DUE TO DISLOCATION. THE HEAD AND LINER WERE EXPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 23497893 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY EIGHT YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO PAIN AND DIFFICULTIES WITH ADLS. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 22157343 ↗
• InjuryMar 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT HAD RIGHT PRIMARY HIP ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION DUE TO RECURRENT DISLOCATIONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 21651478 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED EIGHT (8) YEARS POST IMPLANTATION DUE TO PAIN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 19578743 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Loss of Range of Motion; Pain; Unequal Limb Length

  MAUDE report 19114787 ↗
• InjuryJan 10, 2024Material Erosion; Material Erosion

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY FOUR YEARS POST IMPLANTATION DUE TO PAIN, TENDINITIS, AND ELEVATED COBALT AND CHROMIUM LEVELS. DURING THE REVISION, TRUNNION WEAR WAS NOTED. ADDITIONALLY, THE GREATER TROCHANTER HAD A PARTIAL UNDER-SURFACE DETACHMENT OF THE ABDUCTOR TENDON WITH MODERATE DEGENERATION WHICH INCLUDED THE GLUTEUS MEDIUS AND MINIMUS. THE WELL-FIXED SHELL AND STEM WERE LEFT INTACT, AND ALL THE OTHER COMPONENTS WERE REMOVED AND REPLACED WITHOUT COMPLICATIONS.

  Patient problems: Inflammation; Metal Related Pathology; Muscle/Tendon Damage; Pain

  MAUDE report 18484977 ↗
• InjuryAug 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH ZIMMER BIOMET DEVICES. SUBSEQUENTLY, THE PATIENT WAS REVISED SEVEN YEARS POST IMPLANTATION DUE TO DISLOCATION. THE HEAD AND LINER WERE EXCHANGED.

  Patient problems: Joint Dislocation

  MAUDE report 17574273 ↗
• InjuryJul 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 17298146 ↗
• InjuryJun 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY ONE AND A HALF YEARS LATER DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 17171924 ↗
• InjuryMar 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 16511336 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 16452136 ↗
• InjuryApr 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT IS SUFFERING FROM PAIN, LIMPING, AND IS NOT HAPPY WITH THE IMPLANTS AFTER AN UNKNOWN AMOUNT OF TIME POST INITIAL HIP PROCEDURE. PATIENT REPORTS HAVING SEEN MANY DIFFERENT DOCTORS AND ATTENDED MANY PHYSICAL THERAPY SESSIONS WITH NO PROGRESS. NO REVISION SURGERY HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 14103936 ↗
• InjuryMar 14, 2022Material Erosion; Naturally Worn; Material Erosion; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY THREE (3) YEARS AND FOUR (4) MONTHS POST IMPLANTATION DUE TO WEAR. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 13758354 ↗
• InjuryOct 13, 2021Material Erosion; Unstable; Device Dislodged or Dislocated; Material Erosion; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY REVISION TO ADDRESS PAIN, INSTABILITY, SUBLUXATION AND DISLOCATION APPROXIMATELY NINE (9) YEARS POST-OPERATIVELY. DURING THE REVISION THE SURGEON WAS UNABLE TO REMOVE NECK FROM TAPER, AND ELECTED TO RETAIN STEM AS IT WAS COLD-WELDED. ALL OTHER COMPONENTS WERE REVISED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES IDENTIFIED BROWNISH COLORED FLUID IN THE JOINT AND THE HIP WAS FOUND TO BE DISLOCATED WHEN THE CAPSULE WAS OPENED. THE HEAD, SHELL AND LINER WERE REMOVED AND SOME SIGNIFICANT ANTERIOR WALL BONE LOSS WAS NOTED. THE NECK COULD NOT BE DISASSOCIATED FROM THE STEM AND NEITHER WERE REVISED. NO INTRAOPERATIVE COMPLICATIONS RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED.

  Patient problems: Failure of Implant; Joint Dislocation; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Osteopenia/ Osteoporosis; Pain; Scar Tissue; Subluxation

  MAUDE report 12627830 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION AFTER AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 12447980 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 11 YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN AND SUSPECTED METALLOSIS. THE SURGEON REMOVED KINECTIV HEAD AND NECK AND FOUND VERY LITTLE SIGNS OF WEAR. AS A RESULT, THE SURGEON DECIDED TO REMOVE THE ACETABULAR CUP FOR POSSIBLE LOOSENING. CUP SEEMED WELL FIXED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 12439431 ↗
• InjuryJun 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  UPON REASSESSMENT OF THE REPORTED EVENT, THE HEAD WAS DETERMINED TO BE NOT REPORTABLE AND DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Joint Dislocation

  MAUDE report 12085579 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 2648920.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 12023947 ↗
• InjuryMay 5, 2021Corroded; Material Erosion; Adverse Event Without Identified Device or Use Problem; Corroded; Material Erosion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT LEFT HIP REVISION PROCEDURE APPROXIMATELY 9 YEARS 5 MONTHS DUE TO PAIN AND ELEVATED METAL IONS. DURING THE REVISION, SIGNIFICANT CORROSION WAS OBSERVED BETWEEN THE HEAD AND NECK JUNCTION WITH RESULTANT PSUEDOCAPSULE. THE HEAD AND LINER WERE REPLACED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11776731 ↗
• InjuryMar 19, 2021Corroded; Material Erosion; Adverse Event Without Identified Device or Use Problem; Corroded; Material Erosion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT HIP REVISION SURGERY 10 YEARS POST IMPLANTATION DUE TO PAIN, PSEUDOTUMOR AND ELEVATED METAL ION. DURING THE REVISION, SIGNIFICANT CORROSION WAS OBSERVED BETWEEN THE HEAD AND NECK JUNCTION WITH RESULTANT DAMAGE TO THE SURROUNDING ADDUCTORS. THE HEAD AND LINER WERE REPLACED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; Metal Related Pathology; Muscle/Tendon Damage; Pain

  MAUDE report 11528880 ↗
• InjuryFeb 2, 2021Corroded; Material Erosion; Device Dislodged or Dislocated; Corroded; Material Erosion; Device Dislodged or Dislocated

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

  Patient problems: Ambulation or Postural Difficulties; Host-Tissue Reaction; Joint Dislocation; Local Reaction; Loss of Range of Motion; Muscle/Tendon Damage; Necrosis; Numbness; Pain; Tissue Damage

  MAUDE report 11269635 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND WAS SUBSEQUENTLY REVISED 10 YEARS LATER DUE TO PAIN, INSTABILITY, CUP MIGRATION, LINER WEAR, AND METAL RELATED PATHOLOGY. OPERATIVE NOTE REPORTED INSTABILITY DUE TO POLY LINER DAMAGE WITH VERTICALLY ORIENTATED ACETABULAR COMPONENT. METALLOSIS 2ND TRUNNION WEAR MODULAR NECK AND STEM INTERFACE. TISSUE STAINED WITH GROSS GREYISH BLACK METALLOSIS TYPE TISSUE ON BOTH ACETABULAR AND FEMORAL COMPONENTS. CUP. LINER, HEAD AND STEM REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Metal Related Pathology; No Information; Pain

  MAUDE report 10869448 ↗
• InjuryJul 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 9 MONTHS POST IMPLANTATION DUE TO FRACTURE OF THE LINER COMPONENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 10309731 ↗

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-2579-2017 · Feb 28, 2017 · Terminated
  Por fullct fem st 17x200mm, Sterile,
• Z-2580-2017 · Feb 28, 2017 · Terminated
  Por fullct fem st 18x200mm, 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-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-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.