VerSys® 8018-28-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024144620), received between Jan 9, 2020 and Apr 15, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 13 YEARS LATER DUE TO INFECTION. THE CPT BIPOLAR HEAD WAS EXPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Medical device site infection

  MAUDE report 24887706 ↗
• InjuryJun 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO DISLOCATION. DURING THE PROCEDURE, THE CUP WAS FOUND TO BE MALPOSITIONED, AND THE TRUNNION OF THE NECK WAS IMPINGING ON THE POSTERIOR ELEVATED RIM OF THE ACETABULAR LINER. THE CUP WAS EXPLANTED, AND NEW CUP WAS IMPLANTED IN A BETTER POSITION. THE NECK WAS CHANGED AND ADJUSTED TO ACCOMMODATE THE NEW CUP POSITION. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336775 ↗
• InjuryMay 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 1 YEAR AND 5 MONTHS POST IMPLANTATION DUE TO UNKNOWN REASONS. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 22052708 ↗
• InjuryMar 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  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 (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 21617763 ↗
• InjuryAug 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 20046665 ↗
• InjuryApr 19, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELEVATED METAL ION LEVELS APPROXIMATELY 2 YEARS POST IMPLANTATION. HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Metal Related Pathology

  MAUDE report 14148398 ↗
• MalfunctionApr 15, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED DURING THE INSPECTION OF THE LOANER KIT IN THE (B)(6) WAREHOUSE, IT HAS BEEN DETECTED THAT THE PIECE HAS BEEN RECEIVED WITH PACKAGING OPENED. NO PATIENT INVOLVED. NO SURGERY OCCURRED. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11672313 ↗
• InjuryDec 29, 2020Device 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 11087195 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO REDUCED MOBILITY AND A MRI SCAN SUGGESTING SOME LOCALIZED TISSUE ABNORMALITIES AROUND THE HIP PROSTHESIS. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Limited Mobility Of The Implanted Joint; Tissue Damage

  MAUDE report 9569333 ↗

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-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-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-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-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-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-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-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-1025-2014 · Oct 11, 2013 · Terminated
  HGP II ACETABULAR CUP BON
• Z-1033-2014 · Oct 11, 2013 · Terminated
  6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE

…and 8 more.