VerSys® 8018-32-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024144682), received between Mar 14, 2022 and Jun 3, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 22132730 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 7 YEARS AND 5 MONTHS POST IMPLANTATION THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO UNKNOWN REASONS. THE FEMORAL HEAD AND STEM WERE BOTH REVISED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 18958220 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE UPPER SIDE OF THE HIP AND ALLEGED SENSATION OF THE TENDON MOVING WITHIN THE JOINT APPROXIMATELY 11 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 14938936 ↗
• InjuryMay 25, 2022Corroded; Degraded; Corroded; Degraded

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND ELEVATED COBALT LEVELS APPROXIMATELY 8 YEARS POST IMPLANTATION. DURING THE REVISION, FLUID WAS OBTAINED CONSISTENT WITH TRUNNIONOSIS. IT WAS ALSO NOTED THAT THE CAPSULE WAS VERY THICK CONSISTENT WITH TAPER CORROSION. A NEW FEMORAL HEAD AND LINER WERE PLACED WITHOUT COMPLICATION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Failure of Implant; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 14498009 ↗
• InjuryMar 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO DISLOCATION. THE HEAD AND POLY CUP WERE REMOVED AND REPLACED WITH NEW PRODUCT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 13757217 ↗

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-2581-2017 · Feb 28, 2017 · Terminated
  Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
• Z-2579-2017 · Feb 28, 2017 · Terminated
  Por fullct fem st 17x200mm, Sterile,
• Z-2578-2017 · Feb 28, 2017 · Terminated
  Por fullct fem st 16x200mm, Sterile,
• Z-2580-2017 · Feb 28, 2017 · Terminated
  Por fullct fem st 18x200mm, 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-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-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-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-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-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-1036-2014 · Oct 11, 2013 · Terminated
  CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
• Z-1033-2014 · Oct 11, 2013 · Terminated
  6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE

…and 8 more.