PROFEMUR® PHA00606Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684PHA006061), received between Apr 13, 2020 and Feb 6, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Unstable; Migration; Unstable; Migration

  CLINICAL STUDY # (B)(4). PATIENT # (B)(6) UNDERWENT RE-REVISION SURGERY ON (B)(6) 2020 DUE TO MIGRATION OF THE PROSTHETIC COMPONENTS FROM IMPROPER POSITIONING AND/OR MUSCLE AND FIBROUS TISSUE LAXITY. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21323959 ↗
• InjuryMay 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT INDEX SURGERY ON (B)(6) 2015. HOWEVER, PATIENT HAD PAIN AND RECURRENT INSTABILITY AND UNDERWENT REVISION SURGERY ON (B)(6) 2017. THE CUP, SCREWS, LINER, HEAD AND NECK WERE REVISED. THE STEM PHA00606, STEM REVISION "PROFEMUR® Z", LOT: 068501170 WAS NOT REVISED. THIS REVISION SURGERY HAS BEEN CAPTURED UNDER MICROPORT INCIDENT GROUP (B)(4). DURING REVISION SURGERY, PATIENT WAS IMPLANTED WITH A PHAC1252 PROFEMUR® NECK VAR/VAL 8DG SHORT COBALT CHROME AND A (B)(4) COCR TRANSCEND® FEMORAL HEAD 28MM SLT TAPER X-LONG FROM WRIGHT MEDICAL. PATIENT RECEIVED ALSO A LINER, INSERT AND ACETABULAR SHELL FROM STRYKER MEDICAL. SINCE HER REVISION ON (B)(6) 2017, PATIENT HAS BEEN COMPLAINING OF ISSUES BUT HAS NOT YET INDICATED WHAT THOSE ISSUES ARE. PATIENT WAS TOLD SHE NEEDED ANOTHER REVISION HOWEVER IT HAS NOT BEEN INDICATED IF IT HAS HAPPENED YET. CHROMIUM LEVEL IS CURRENT 0.2.

  Patient problems: Pain

  MAUDE report 14490661 ↗
• InjuryDec 28, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, THE PATIENT HAS PAIN AND LOOSENING.

  Patient problems: Pain

  MAUDE report 13096168 ↗
• InjuryApr 13, 2020Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  ALLEGEDLY, STEM MIGRATION DUE TO STEM LOOSENING. (RIGHT HIP). RESULTING IN A DEVICE REPLACEMENT WITH NO MPO DEVICE.

  Patient problems: No Information

  MAUDE report 9954284 ↗