VerSys® Advocate® 7850-15-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024138261), received between Jun 20, 2023 and Jun 20, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K950312); 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.

• InjuryJun 20, 2023Unstable; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED A FALL OCCURRED ON AN UNKNOWN DATE AND EXPERIENCED PAIN AND INSTABILITY. IMAGING REVEALED NONUNION OF GREATER TROCHANTER FRACTURE. THE PATIENT UNDERWENT A REVISION APPROXIMATELY 2.5 YEARS AFTER INITIAL SURGERY. THE SHELL WAS RETAINED, AS NOTED TO BE WELL FIXED. SURGEON CONFIRMED ASEPTIC LOOSENING AT CEMENT MANTLE, AND PATIENT HAD BEEN EXPERIENCING ANTERIOR AND POSTERIOR IMPINGEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Fall; Joint Impingement; Osteopenia/ Osteoporosis; Pain

  MAUDE report 17163870 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K950312. 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