PROFEMUR® PRTLEL24Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684PRTLEL241), received between Apr 6, 2022 and Apr 6, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (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. 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.

• InjuryApr 6, 2022Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, AFTER CONFIRMING THE FINAL TRIAL, THE STEM WAS DRIVEN IN, BUT IT FLOATED ABOUT 2 MM, SO IT WAS DRIVEN IN HARD. ALTHOUGH A SUSPICIOUS SHADOW WAS CONFIRMED BY POSTOPERATIVE X-RAY, IT WAS DECIDED TO FOLLOW UP THE PATIENT. THE NEXT DAY, WE SUSPECTED MOBILITY AND CONFIRMED IT WITH X-RAYS AND CT. A FRACTURE WAS FOUND. IN ADDITION, HE DEVELOPED HYPERTENSIVE ENCEPHALOPATHY AND CARDIAC DISEASE, AND HIS DEMENTIA IS DIFFICULT TO CONTROL. IT WAS DETERMINED THAT REOPERATION WAS NOT POSSIBLE. HE IS NOW WEARING A PROTECTIVE HIP BRACE AND WILL BE LOADED IN AT LEAST 8 WEEKS. THE PATIENT DOES NOT COMPLAIN OF PAIN, BUT WE BELIEVE IT IS DUE TO DEMENTIA. (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 14024553 ↗