NA 129966Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010087515), received between Nov 17, 2020 and Nov 17, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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.

• InjuryNov 17, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED, THE FEMORAL HEAD DISASSOCIATED WITH THE STEM. A REVISION SURGERY WAS NECESSARY; THE SALES REPRESENTATIVE ATTENDED THE REVISION, WHERE THE SURGEON NOTICED SEVERE DAMAGE TO THE STEMS TRUNNION AND HAD TO REMOVE THE STEM IN ORDER TO PROCEED WITH A FULL REVISION. WHEN THE FEMORAL HEAD WAS RETRIEVED, IT WAS CONFIRMED THAT THE WRONG TAPER WAS ORIGINALLY USED AND WAS ULTIMATELY THE CAUSE OF THE DISASSOCIATION/DAMAGE. THE PATIENT CURRENT STATUS OF HEALTH IS UNKNOWN. THE STEM THAT HAD BEEN INITIALLY IMPLANTED WAS A SIZE 0 STANDARD COLLARED POLARTSTEM, AND INSTEAD OF THE CORRECT 12/14 TAPERED FEMORAL HEAD, A 32MM +8 LARGE TAPERED 14-16 HEAD WAS ACCIDENTALLY PICKED BY THE NURSING STAFF AND IMPLANTED INTO THE PATIENT. THE SALES REPRESENTATIVE HAD NOT BEEN PRESENT DURING THIS SURGERY, AS COVID-19 RESTRICTIONS PROHIBITED VENDORS FROM ENTERING THE HOSPITAL AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Injury; Joint Dislocation

  MAUDE report 10857510 ↗