VerSys® 8018-32-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00889024144675), received between Feb 25, 2020 and Aug 11, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 reports).

23 other recalls cover devices cleared under the same FDA submission (K840643, 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 22779140 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 4 AND A HALF YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INSTABILITY. THE HEAD AND LINER WERE EXCHANGED.IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22051932 ↗
• InjuryOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 20454386 ↗
• InjuryJul 23, 2024Material Erosion; Material Erosion

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Metal Related Pathology; Tissue Breakdown

  MAUDE report 19808840 ↗
• InjuryFeb 27, 2024Material Erosion; Insufficient Device Problem Information; Material Erosion; Insufficient Device Problem Information

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Failure of Implant; High metal ion levels; Insufficient Information; Muscle/Tendon Damage; Necrosis; Osteolysis; Pain

  MAUDE report 18790482 ↗
• InjuryJun 19, 2023Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY SIX (6) YEARS LATER DUE TO PAIN, ELEVATED METAL IONS, AND METALLOSIS. DURING THE REVISION, TRUNNIONOSIS WAS NOTED WITH METAL DEBRIS AND METALLOSIS. THE HEAD, AND ACETABULAR LINER WERE EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; High metal ion levels; Metal Related Pathology; Pain

  MAUDE report 17151748 ↗
• InjuryOct 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO CHRONIC DISLOCATION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 15546620 ↗
• InjuryApr 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 13977448 ↗
• InjuryFeb 10, 2022Corroded; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Corroded; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION DUE TO METALLOSIS DURING THE PROCEDURE THE HEAD AND LINER WERE REVISED WITHOUT COMPLICATION. NO ALLEGATIONS AGAINST LINER, SURGEON SAID THE POLY LOOKED GOOD. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Fatigue; Hearing Impairment; High metal ion levels; Metal Related Pathology; Pain; Tinnitus

  MAUDE report 13508000 ↗
• InjuryNov 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 12738595 ↗
• InjuryOct 25, 2021Corroded; Material Erosion; Corroded; Material Erosion

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ELEVATED ION LEVELS, JOINT INFECTION AND METALLOSIS APPROXIMATELY 9 YEARS POST IMPLANTATION. IT WAS ALSO NOTED THAT THE PATIENT SUFFERED FROM LOSS OF CIRCADIAN RHYTHM, LOSS OF DEEP SLEEP, COMPLETE LOSS OF SHORT-TERM MEMORY, PARTIAL LOSS OF LONG-TERM MEMORY, LOSS OF EXECUTIVE FUNCTIONS (ORGANIZING ETC), HYPERSENSITIVITY OF TASTE (TOO SWEET, TOO SALTY), LOSS OF APPETITE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Anemia; Atrial Fibrillation; Decreased Appetite; Extraskeletal ossification; Inflammation; Memory Loss/Impairment; Metal Related Pathology; Necrosis; Pain; Scar Tissue; Sleep Dysfunction; Swelling/ Edema; Synovitis; Taste Disorder; Unspecified Nervous System Problem

  MAUDE report 12693171 ↗
• InjuryOct 13, 2021Corroded; Material Erosion; Corroded; Material Erosion

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

  Patient problems: Fibrosis; Metal Related Pathology; Necrosis; Pain

  MAUDE report 12629103 ↗
• InjuryOct 13, 2021Corroded; Material Erosion; Corroded; Material Erosion

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

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 12627651 ↗
• InjuryOct 7, 2021Corroded; Material Erosion; Corroded; Material Erosion

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

  Patient problems: Inflammation; Metal Related Pathology; Necrosis; Pain; Scar Tissue

  MAUDE report 12592600 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENTS¿ LEGAL COUNSEL THAT THE PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT HAS FILED AN UNKNOWN ALLEGATION ON THE HIP APPROXIMATELY 4 YEARS LATER. NO REVISION HAS BEEN REPORTED TO DATE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 12578283 ↗
• InjuryApr 1, 2021Corroded; Corroded

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

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11604273 ↗
• InjuryMar 10, 2021Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO METALLOSIS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Metal Related Pathology

  MAUDE report 11456946 ↗
• InjuryFeb 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY 10 MONTHS POST IMPLANTATION, THE PATIENT FELL FROM BED AND EXPERIENCED A DISLOCATION. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT A CLOSED REDUCTION PROCEDURE ON AN UNKNOWN DATE DUE TO RECURRENT DISLOCATIONS. THE PATIENT HAS BEEN INDICATED FOR A REVISION PROCEDURE USING A CUSTOM DEVICE; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 11292161 ↗
• InjuryDec 8, 2020Material Erosion; Material Erosion

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

  Patient problems: No Information

  MAUDE report 10968481 ↗
• InjuryAug 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT HIP REPLACEMENT SURGERY. FOUR DAYS AFTER SURGERY, AN XRAY WAS TAKEN AND CONFIRMED THAT THE IMPLANT HAD DISLOCATED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 10369357 ↗
• InjuryFeb 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE AND DISLOCATION APPROXIMATELY 42 DAYS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 9749863 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K840643, 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-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-1683-2016 · May 4, 2016 · Terminated
  Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 006624
• Z-1131-2016 · Jan 11, 2016 · Terminated
  Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETA
• Z-1126-2016 · Jan 11, 2016 · Terminated
  Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28M
• Z-1110-2016 · Jan 11, 2016 · Terminated
  Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COC
• Z-1137-2016 · Jan 11, 2016 · Terminated
  Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IM
• 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-1036-2014 · Oct 11, 2013 · Terminated
  CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
• Z-1034-2014 · Oct 11, 2013 · Terminated
  6 DEGREE COCR FEM HEAD 36

…and 8 more.