VerSys® 7859-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024138667), received between Feb 26, 2021 and Feb 26, 2021 — classified as 1 injury.

3 other recalls cover devices cleared under the same FDA submission (K950312, K954744); 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. How this data works · Data updated Oct 13, 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 11386102 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K950312, K954744. One submission often covers many models, so check the product and lot details in each record.

• Z-1167-2016 · Jan 11, 2016 · Terminated
  Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF 785301601
• Z-1164-2016 · Jan 11, 2016 · Terminated
  Product 66 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE
• 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