PROFEMUR® PRTL0026Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M684PRTL00261), received between Feb 17, 2020 and Apr 18, 2024 — classified as 7 injuries.

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

• InjuryApr 18, 2024Difficult to Insert; Difficult to Insert

  ALLEGEDLY, THERE WAS A CASE OF BHA AT NISHINARA CENTRAL HOSPITAL, WHERE TLBHA WAS SCHEDULED AND TL WAS RASPED UP TO 6. TL6 WAS USED FOR GENUINE INSERTION, BUT WHEN THE IMPLANT WAS PLACED, IT FLOATED ABOUT 3MM, AND WHEN IT WAS PLACED TO THE PROPER HEIGHT, BONE CRACKING OCCURRED. THE IMPLANT WAS REMOVED WITH AN EXTRACTOR AND REPLACED WITH AN XM, AND THE OP WAS SUCCESSFULLY COMPLETED. (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 19129884 ↗
• InjuryJul 11, 2022Corroded; Corroded

  ALLEGEDLY, ON OR ABOUT (B)(6) 2011 PATIENT HAD A WRIGHT ARTIFICIAL HIP IMPLANTED IN HIS LEFT HIP, IN A PROCEDURE KNOWN AS A TOTAL HIP ARTHROPLASTY ( OR"THA"). FOLLOWING COMPLAINTS OF PAIN AND PHYSICAL LIMITATIONS, PATIENT REPORTED FOR REVISION SURGERY OF HIS LEFT HIP PROSTHESIS. PATIENT'S REVISION SURGERY WAS NECESSARY DUE TO PAIN CAUSED BY FRETTING AND CORROSION AT THE MIXED METAL JUNCTION AT THE COCR MODULAR NECK AND TITANIUM STEM. IN THE COURSE OF THE REVISION SURGERY SURGEON REMOVED PATIENT'S WRIGHT MEDICAL HIP COMPONENTS ON THE LEFT SIDE, INCLUDING THE MODULAR STEM AND NECK. IT WAS DISCOVERED THAT THE PROFEMUR® COCR MODULAR NECK IMPLANTED IN PATIENT'S LEFT HIP FAILED, MEANING THAT DUE TO CORROSION OF THE OBLONG TAPER OF THE COCR MODULAR NECK WHERE IT SEATED IN THE POCKET OF THE PROFEMUR® TITANIUM STEM IT WAS CAUSING PHYSICAL INJURY TO THE PATIENT.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 14978025 ↗
• 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, (B)(6), 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: (B)(4). (B)(4).

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 14134740 ↗
• InjuryFeb 7, 2022Difficult to Remove; Difficult to Remove

  ALLEGEDLY, TI MODULAR NECK BROKE WHEN PT PICKED UP A POTTED PLANT. ATTEMPTED TO REMOVE WITH MPO REMNANT REMOVAL TRAY, 2 DRILL BITS AND A TAP BROKE IN THE PROCESS. SURGEON ALSO ATTEMPTED TO BUR OUT NECK WITH METAL BUR, THIS ALSO DID NOT WORK. SURGEON ALSO ATTEMPTED TO REMOVE WITH OSTEOTOMES, THIS DID NOT WORK. AFTER 4 HOURS THE SURGEON WAS FINALLY ABLE TO REMOVE THE STEM BY PERFORMING AN ETO. IMPLANTS NOT REVISED: PARTID: CONSERVE® PLUS CUP 56MM ID 62MM OD BEADED, ITEM#38025662, LOT#087457365, QTY:1.

  Patient problems: Insufficient Information

  MAUDE report 13473303 ↗
• InjuryDec 31, 2021Corroded; Corroded

  ALLEGEDLY, FOLLOWING COMPLAINTS OF PAIN AND PHYSICAL LIMITATIONS, PATIENT REPORTED FOR REVISION SURGERY OF HIS LEFT HIP PROTHESIS. PATIENT´S REVISION SURGERY WAS NECESSARY DUE TO PAIN CAUSED BY A FAILED METAL ON METAL JUNCTION CORROSION ISSUE AT THE COCR MODULAR NECK AND TITANIUM STEM. IN THE COURSE OF THE REVISION SURGERY THE SURGEON REMOVED PATIENT?S WRIGHT MEDICAL HIP COMPONENTS, INCLUDING THE MODULAR NECK AND STEM.

  Patient problems: Pain

  MAUDE report 13124946 ↗
• InjuryJul 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE STEM. REVISION NJR NUMBER: (B)(4) SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED: PROCOTYL L BEADED AND HA COATED CUP SIZE 58MM PRODUCT ID PHA06268 LOT ID 111. RIM-LOCK BIOLOX DELTA CERAMIC LINER 36MM ID GROUP F PRODUCT ID PHA04512 LOT ID 111.

  Patient problems: Bone Fracture(s)

  MAUDE report 10337533 ↗
• InjuryFeb 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ELEVATED COBALT ION LEVELS, PAIN AND STIFFENS OF THE HIP. IT WAS DISCOVERED THAT THE DEVICE FAILED DUE TO CORROSION OF THE OBLONG TAPER OF MODULAR NECK WHERE IT SEATED IN THE POCKED OF THE TITANIUM STEM.

  Patient problems: Pain

  MAUDE report 9716857 ↗