VerSys Heritage® 7857-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024138452), received between Feb 26, 2021 and Feb 26, 2021 — classified as 1 injury.

3 other recalls cover devices cleared under the same FDA submission (K963109); 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 18, 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.

• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A HIP HEMIARTHROPLASTY (SURGERY DUE TO A TRAUMA RELATED SUBCAPITAL HIP FRACTURE) IN AN ELDERLY FEMALE, THE PATIENT SUFFERED A PULMONARY EMBOLISM AND DIED INTRAOPERATIVELY. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. IF A DVT/ BLOOD CLOT OR FAT EMBOLISM BREAKS FREE, IT MAY TRAVEL THROUGH THE BLOODSTREAM AND BLOCK BLOOD FLOW TO THE LUNGS. THIS COMPLICATION IS CALLED A PULMONARY EMBOLISM WHICH CAN QUICKLY TURN FATAL. AS THIS IS A PROCEDURE-RELATED AND PATIENT CONDITION RELATED EVENT, THE DEVICE CAN BE RULED OUT AS CAUSING OR CONTRIBUTING TO THE EVENT. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 11386071 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963109. One submission often covers many models, so check the product and lot details in each record.

• Z-1168-2016 · Jan 11, 2016 · Terminated
  Product 70 consists of all product under product code: JDI and same usage: Item no: 785701000 VERSYS HERITAGE FEM STEM 785701100 VERSYS HERITAGE FEM STEM 785701200 VERSYS HERITAGE
• 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.