VerSys® 8018-36-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024144712), received between Apr 8, 2020 and Sep 19, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Material Erosion” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 1 YEAR POST IMPLANTATION DUE TO HAVING PAIN AND DIFFICULTY AMBULATING. SUBSEQUENTLY, THE PATIENT CONTINUED TO EXPERIENCE PAIN, DIFFICULTY AMBULATING, SWELLING, AND IMPAIRED HEALING. THE PATIENT ALLEGES LEG LENGTH DISCREPANCY AND A SYSTEMIC ALLERGIC REACTION TO THE IMPLANT COATING. ADDITIONALLY, THE PATIENT ALLEGES THAT THE POSTERIOR SCREW OF THE CUP IS MIGRATING AND PENETRATING THE GLUTEN MUSCLES AND CAUSING FEMORAL AND SCIATIC NERVE DAMAGE AND NEUROPATHY. NO MEDICAL RECORDS HAVE BEEN PROVIDED THUS FAR. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.

  Patient problems: Ambulation or Postural Difficulties; Deformity/ Disfigurement; Fever; Hypersensitivity/Allergic reaction; Itching Sensation; Loss of Range of Motion; Nerve Damage; Neuropathy; Pain; Skin Discoloration; Swelling/ Edema; Unequal Limb Length

  MAUDE report 23094540 ↗
• InjuryJun 25, 2024Corroded; Material Erosion; Corroded; Material Erosion

  INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED DUE TO A FALL RESULTING IN A DISPLACED RIGHT TRANSCERVICAL FEMORAL NECK FRACTURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN AND ELEVATED METAL ION LEVEL. DURING THE REVISION A BLACKENED LINE WAS NOTED AROUND THE INTERFACE BETWEEN THE HEAD AND THE PROSTHETIC NECK, CONSISTENT WITH CORROSION OR TRUNNIONOSIS. THE STEM WAS NOTED TO BE WELL FIXED. THE LINER AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS.

  Patient problems: Fall; High metal ion levels; Metal Related Pathology; Pain; Scar Tissue

  MAUDE report 19608906 ↗
• InjuryDec 11, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY SEVEN YEARS POST IMPLANTATION DUE TO RECURRING DISLOCATIONS. DURING THE PROCEDURE, THE SURGEON ENCOUNTERED A LARGE AMOUNT OF EDEMA IN THE SUBCUTANEOUS TISSUES, OSTEOLYSIS WITH OSTEOLYTIC TISSUE, AND INSTABILITY. THE SURGEON ALSO FOUND HETEROTOPIC BONE OF THE ACETABULUM AND FEMUR, LARGE PSEUDOTUMOR WITH SOFT TISSUE NECROSIS, TRUNNIONOSIS, POLY WEAR, AND METALLOSIS THROUGHOUT ALL THE TISSUES. ALL THE IMPLANTS, EXCEPT FOR THE STEM, WERE REVISED WITHOUT FURTHER COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Pain

  MAUDE report 18303773 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS APPROXIMATELY 5 YEARS POST IMPLANTATION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12293710 ↗
• InjuryMay 14, 2021Material Erosion; Material Erosion

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

  Patient problems: Failure of Implant; Metal Related Pathology; Muscle/Tendon Damage; Pain; Scar Tissue

  MAUDE report 11824534 ↗
• InjuryApr 8, 2020Loss of or Failure to Bond; Loss of Osseointegration; Loss of or Failure to Bond; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT A LEFT HIP REVISION APPROXIMATELY 10 MONTHS POST IMPLANTATION DUE TO SEVERE PAIN. THE PATIENT WAS NOTED TO HAVE VERY POOR BONE QUALITY. DURING THE REVISION PROCEDURE, THE ACETABULAR SHELL WAS NOTED TO BE LOOSE WITH INADEQUATE OSSEOINTEGRATION. ONE OF THE SCREWS WAS NOTED TO HAVE PULLED THROUGH THE SHELL. METALLOSIS WAS DEBRIDED FROM THE JOINT AND THE HEAD, LINER AND SHELL COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Osteopenia/ Osteoporosis; Pain; Reaction

  MAUDE report 9937842 ↗

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-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-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-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-1034-2014 · Oct 11, 2013 · Terminated
  6 DEGREE COCR FEM HEAD 36
• Z-1031-2014 · Oct 11, 2013 · Terminated
  12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
• 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.