Profemur PHA01232Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI M684PHA012321), received between Jan 27, 2017 and Jun 10, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  ALLEGEDLY, ORIGINAL SURGERY DONE IN 2004, EXACT DATE UNKNOWN. RECENTLY THE PATIENT SUFFERED HIP PAIN AND UNDERWENT A REVISION HIP REPLACEMENT. THE MODULAR NECK, CONSERVE BIG FEMORAL HEAD AND CONSERVE CUP WERE REVISED, AND REPLACED WITH A S&N ACETABULAR SHELL AND LINER (THE SURGEONS STANDARD PRODUCT). A NEW MODULAR NECK WAS INSERTED, ALONG WITH AN MPO CERAMIC HEAD.

  Patient problems: Pain

  MAUDE report 19504670 ↗
• InjuryApr 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ALLEGEDLY, THE HEAD DISLOCATED FROM THE CUP AND DURING REPAIR, THE NECK DISASSOCIATED FROM THE STEM. ON MONDAY, MARCH 21, SURGEON TRIED TO REPAIR THE DISLOCATION, AFTER 30 MINUTES, IT COULD NOT BE REPAIRED, AND LATER, THE DISASSOCIATION WAS CONFIRMED BY X-RAY. DOCTOR'S FINDING:THE PATIENT MAY HAVE DISASSOCIATED DURING THE TRACTION MOVEMENT AT THE TIME OF THE REPAIR. COMPONENT NOT REVISED: PRTL0026 / PROFEMUR TL STEM SIZE6 / LOT 17230401908970 / QTY 1. (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 14134785 ↗
• InjuryOct 12, 2021Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  ALLEGEDLY, THE PATIENT DISLOCATED A FEW DAYS AFTER THE ORIGINAL SURGERY, THIS WAS REDUCED AND THE PATIENT WAS OK FOR ABOUT 10 DAYS. BEFORE THERE WAS A FURTHER DISLOCATION THE SURGEON FELT THAT THE REASON FOR THE DISLOCATION WAS A LACK OF TENSION, OR OFFSET. THIS WAS RESOLVED WITH A LONGER NECK, CREATING MORE OFFSET. THE OPERATION WAS COMPLETED SUCCESSFULLY, THE PATIENT HAS SINCE BEEN DISCHARGED FROM HOSPITAL. THE SURGEON PUTS THIS DOWN TO SURGEON ERROR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12615410 ↗
• InjuryApr 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, REVISION #2 - THE PATIENT WAS REVISED DUE TO DISLOCATION. (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 11679088 ↗
• InjuryMar 2, 2021Corroded; Corroded

  ALLEGEDLY, THE SUBJECT WAS REVISED DUE TO METALLOSIS AND CORROSION ALONG THE TAPER.

  Patient problems: Metal Related Pathology

  MAUDE report 11400025 ↗
• InjuryNov 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION SUBLUXATION; MALALIGNMENT SOCKET; PERIPROSTHETIC FRACTURE STEM REVISION NJR NUMBER: (B)(6). SIDE:R. PRIMARY ASA: P1 - FIT AND HEALTHY. (B)(4).

  Patient problems: No Information

  MAUDE report 10913565 ↗
• InjuryJul 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION+BONE FRACTURE. COMPONENTS NOT REVISED: PPR67352 COTYLE "ANCA FIT?" SANS TROUS A/REVET. HAP 52 LOT U1088757, PPR6-7612 TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 13D LOT 098634518. PPR67510 INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE. LOT: U11145690.

  Patient problems: No Information

  MAUDE report 10353177 ↗
• InjuryMay 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO STEM ASEPTIC LOOSENING+PROSTHESIS DISLOCATION.

  Patient problems: No Information

  MAUDE report 10063384 ↗
• InjuryApr 13, 2020Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  ALLEGEDLY, LEFT HIP ENDOPROSTHESIS DISLOCATION DUE TO EXTENSIVE INTERNAL ROTATION OF THE HIP JOINT, CLOSED REDUCTION AND IMMOBILISATION RESOLVED THE PROBLEM, NO FURTHER INSTABILITY OF THE ENROLLED HIP.

  Patient problems: No Information

  MAUDE report 9953578 ↗
• InjuryMar 17, 2020Break; Corroded; Break; Corroded

  ALLEGEDLY, ON (B)(6) 2019 PATIENT WAS NOTIFIED THAT SHE SUFFERED PSEUDOTUMOR IN HER LEFT HIP, WITH CONCERN ABOUT FRICTION, CORROSION AND FAILURE OF HER PROFEMUR MODULAR NECK, AS WELL AS CONCERN OVER MIGRATION OF THE DYNASTY LINER.. THE STRUCTURAL FAILURE OF THE TITANIUM PROFEMUR MODULAR NECK COMPONENTS WAS THE RESULT OF A FATIGUE FAILURE OF THE TITANIUM, CAUSED OVER TIME BY CYCLIC LOADING OF THE DEVICE, RESULTING IN THE RELEASE OF METAL PARICLES WITHIN LEFT HIP JOINT. ON (B)(6) 2019 PATIENT RECEIVED A REVISION SURGERY AND THE STEM, MODULAR NECK AND ALL OTHER COMPONENTS WERE REMOVED AND REPLACED, THE TITANIUM MODULAR NECK HAD CORRODED AND FATIGUED, AND THE DYNASTY LINER HAVING MIGRATED.

  Patient problems: Reaction

  MAUDE report 9844814 ↗
• InjuryJan 27, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY REVISED DUE TO DISLOCATION SUBLUXATION. ADDITIONAL PRODUCT INFORMATION RECEIVED ON 1/12/2017: NECK PRODUCT INFORMATION NOW AVAILABLE.

  Patient problems: No Information

  MAUDE report 6283038 ↗