VerSys® 8018-28-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024144613), received between Aug 5, 2020 and Dec 4, 2024 — classified as 4 injuries, 1 malfunction.

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.

• InjuryDec 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Joint Dislocation

  MAUDE report 20846308 ↗
• InjuryFeb 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 16293616 ↗
• InjuryOct 27, 2022Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 6 MONTHS POST IMPLANTATION DUE TO A DISLOCATION, CONFIRMED BY XRAYS. DURING THE PROCEDURE, IT WAS NOTED THAT THE HEAD CAME APART FROM THE INSERT. THE COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15686954 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 11275453 ↗
• MalfunctionAug 5, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. DURING THE PROCEDURE A SIZE 7.5 ML TAPER STEM WITH A -3.5MM NECK LENGTH FEMORAL HEAD AND 44MM BIPOLAR SHELL AND LINER WAS OPENED FOR IMPLANTATION INTO THE PATIENT, AFTER A TRIAL REDUCTION PROCESS APPEARED TO REVEAL SATISFACTORY JOINT LAXITY AND LIMB LENGTH. AFTER ACTUAL IMPLANTATION OF IMPLANTS AND SUBSEQUENT REDUCTION OF THE IMPLANT CONSTRUCT, JOINT LAXITY APPEARED TO BE DISSATISFACTORY. IT WAS UNCLEAR WHETHER THERE WAS ANY SUBSIDENCE OF THE ACTUAL STEM IMPLANT VS THE TRIAL INSTRUMENT. IT WAS ALSO UNCLEAR WHETHER THERE WAS ANY SUBSIDENCE OF THE ACTUAL STEM IMPLANT IN-SITU DURING THE REDUCTION PROCESS. A NEW FEMORAL HEAD, NOW A +0MM NECK LENGTH, WAS USED INSTEAD, AND SURGICAL REDUCTION REVEALED JOINT LAXITY THAT WAS LESS DISSATISFACTORY THAN THE PREVIOUS FEMORAL HEAD. THIS WAS THEN ACCEPTED BY THE SURGEON. THE SURGICAL PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10367419 ↗

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-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-2580-2017 · Feb 28, 2017 · Terminated
  Por fullct fem st 18x200mm, Sterile,
• 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-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-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-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-1033-2014 · Oct 11, 2013 · Terminated
  6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
• Z-1036-2014 · Oct 11, 2013 · Terminated
  CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)

…and 8 more.