VerSys® 7871-13-62Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024140042), received between Sep 25, 2024 and Sep 25, 2024 — classified as 1 death.

5 other recalls cover devices cleared under the same FDA submission (K210842, K913649); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathSep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON AN UNKNOWN DATE USING A COMPETITOR'S IMPLANTS. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR A PERIPROSTHETIC FRACTURE. DURING THE REVISION HEMI ARTHROPLASTY SURGERY, THE PATIENT'S CONDITION DETERIORATED, AND THE PATIENT DIED OF CARDIOPULMONARY ARREST. IT IS NOT KNOWN WHETHER THE PATIENT HAD ANY UNDERLYING MEDICAL CONDITIONS THAT MAY HAVE BEEN RELATED TO THE EVENT. THE PATIENT'S CARDIOPULMONARY ARREST OCCURRED AFTER THE BONE CEMENT AND STEM WERE INSERTED INTO THE PATIENT. THE CEMENT IS A COMPETITOR PRODUCT. THE CAUSE OF THE CARDIOPULMONARY ARREST WAS NOT DETERMINED; HOWEVER, NO CAUSAL RELATIONSHIP BETWEEN THE DEATH AND THE PRODUCT HAS BEEN NOTED. THERE WAS NO PATIENT INFORMATION OR MEDICAL RECORDS AVAILABLE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Cardiac Arrest

  MAUDE report 20300079 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210842, K913649. One submission often covers many models, so check the product and lot details in each record.

• Z-1166-2016 · Jan 11, 2016 · Terminated
  Product 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CEM/REV/CALCAR 13X 787101362 VERSYS CEM/RE
• Z-0610-2014 · Dec 10, 2013 · Terminated
  Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction tech
• Z-0608-2014 · Dec 10, 2013 · Terminated
  CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients
• Z-1029-2014 · Oct 11, 2013 · Terminated
  12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX S
• Z-0277-2014 · Aug 28, 2013 · Terminated
  VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.