Profemur PHA01254Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI M684PHA012541), received between Jul 27, 2016 and Jun 21, 2024 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (16 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2024Break; Break

  ALLEGEDLY, BROKEN MODULAR NECK. NON REVISED PRODUCTS: PRODUCT ID: DSPCGG58 DYNASTY® PC SHELL 58MM GROUP G/ LOT NO.: 038567109/ QTY: 1.

  Patient problems: Insufficient Information

  MAUDE report 19587749 ↗
• InjuryJun 18, 2024Break; Break

  ALLEGEDLY, BROKEN MODULAR NECK.

  Patient problems: Insufficient Information

  MAUDE report 19559441 ↗
• InjuryMar 5, 2024Break; Break

  ALLEGEDLY, ON (B)(6) 2005, PATIENT UNDERWENT A TOTAL RIGHT HIP REPLACEMENT AT (B)(6) HOSPITAL BY A SURGEON FOR PROGRESSIVE PAIN AND DYSFUNCTION SECONDARY TO END-STAGE ARTHROSIS OF HIS RIGHT HIP. ON OR ABOUT ON (B)(6) 2022, WHILE RELAXING IN A LIVING ROOM CHAIR, PATIENT HAD THE SENSATION THAT SOMETHING INSIDE HIM BROKE AND THEN FELT EXCRUCIATING PAIN IN HIS RIGHT HIP AND RADIATING INTO HIS GROIN. PATIENT WAS TRANSPORTED TO (B)(6) CENTER, WHERE X-RAYS REVEALED "A FRACTURE OF THE FEMORAL COMPONENT. PATIENT REMAINED HOSPITALIZED AT (B)(6) UNTIL ON (B)(6) 2022, WHEN HE WAS TRANSPORTED, VIA AMBULANCE, TO (B)(6) HOSPITAL WHERE HE UNDERWENT REVISION SURGERY ON (B)(6) 2022, BY SURGEON. SURGEON FINDINGS: PATIENT IS NOW 17 YEARS AFTER INDEX RIGHT TOTAL HIP ARTHROPLASTY. HE HAS HAD REASONABLY GOOD FUNCTION, BUT UP UNTIL THE LAST FEW MONTHS, HE HAS HAD SOME SYMPTOMS, BUT REALLY HAS MAINTAINED STABILITY OF THE IMPLANT. ON FRIDAY ON (B)(6) 2022, HE WAS GETTING UP FROM A CHAIR AND FELT A CLICK IN HIS HIP AND WAS UNABLE TO BEAR WEIGHT AND HE HAD IMMEDIATE PAIN. HE HAD REALLY QUITE A LOT OF PAIN, LIMITATION OF HIS FUNCTION SINCE THAT TIME. HISTORY, PHYSICAL EXAMINATION, RADIOGRAPH SHOWS WHAT APPEARS

  Patient problems: Pain

  MAUDE report 18841671 ↗
• InjuryNov 28, 2023Mechanical Jam; Mechanical Jam

  ALLEGEDLY, UNABLE TO REMOVE THE NECK, THE ENTIRE STEM WAS REMOVED. REPORTING PARTY'S FINDINGS AND RESPONSE STATUS: THERE MAY HAVE BEEN IMPURITIES IN THE NECK-STEM JOINT, OR THE STEM MAY HAVE STUCK DUE TO COLD FLOW. ADDITIONAL INFORMATION RECEIVED ON 2023-11-09: DURING NECK REMOVAL, THE STEM CAME OUT UNINTENTIONALLY (IS IT POSSIBLE THAT THE FIXATION OF THE STEM TO THE BONE WAS INSUFFICIENT). ADDITIONAL INFORMATION RECEIVED ON 2023-11-13: THE PRIMARY REASON FOR REVISION INVOLVED LOOSENING OF A NON-MPO CEMENTED CUP. DURING THIS SURGERY, THE PLAN WAS TO REVISE THE NECK AND HEAD UNLESS INFECTION/LOOSENING OF THE STEM WAS ALSO FOUND. NO INFECTION WAS FOUND, AND ONLY THE NECK WAS TO BE REMOVED. HOWEVER, THE SURGICAL TEAM COULD NOT REMOVE THE NECK FROM THE STEM WHICH RESULTED IN FULL REVISION OF THE FEMORAL STEM AS WELL. JAPAN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18216289 ↗
• MalfunctionOct 23, 2023Break; Break

  ALLEGEDLY, TI NECK FX CLAIM (10+). LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 17987080 ↗
• InjuryJun 1, 2023Break; Break

  ALLEGEDLY, MODULAR NECK FRACTURE LEFT HIP. ADDITIONAL INFORMATION RECEIVED ON 2023-07-06: THE PATIENT SUDDENLY FELT PAIN IN THE AREA OF THE LEFT HIP WITHOUT TRAUMA SINCE THEN HE CAN NO LONGER PUT FULL WEIGHT ON THE LEFT HIP. NON-MPO COMPONENTS: PRODUCT ID: 0805M8N0158 IMPLANTEC GMBH OF GRENZGASSE 38A, 2340 MÖDLING/ LOT NUMBER: 90621-A/ QTY: (B)(4).

  Patient problems: Insufficient Information; Pain

  MAUDE report 17043383 ↗
• InjuryAug 29, 2022Break; Break

  ALLEGEDLY, ON (B)(6), 2007, PATIENT HAD A WRIGHT MEDICAL ARTIFICIAL HIP IMPLANTED IN THE RIGHT SIDE OF HIS BODY IN A PROCEDURE KNOWN AS A TOTAL HIP ARTHROPLASTY (THA). ON (B)(6), 2021, PATIENT'S PROFEMUR HIP SUDDENLY STRUCTURALLY FAILED, BREAKING INTO TWO PIECES AT THE OBLONG TAPER OR DISTAL END OF THE DEVICE, WHERE IT SEATED IN THE POCKET OF THE PROFEMUR STEM. THE STRUCTURAL FAILURE OF THE TITANIUM PROFEMUR® MODULAR NECK COMPONENT OF PATIENT'S ARTIFICIAL HIP WAS THE RESULT OF A FATIGUE FAILURE OF THE TITANIUM, CAUSED OVER TIME BY CYCLIC LOADING OF THE DEVICE, UNTIL MORE THAN 90% OF THE DISTAL END OBLONG TAPER HAD FRACTURED THROUGH ITS CROSS SECTION, AND THE REMAINING CONNECTED METAL THEN SUFFERED A TENSILE FAILURE, RESULTING IN A COMPLETE FRACTURE OF THE MODULAR NECK. BECAUSE OF THE FRACTURE OF PATIENT'S PROFEMUR MODULAR NECK IT WAS NECESSARY FOR HIM TO HAVE EMERGENCY SURGERY PERFORMED TO REMOVE THE FAILED DEVICE. ON (B)(6) 2021, ORTHOPEDIC SURGEON, PERFORMED UPON PATIENT'S HIP A REVISION HIP SURGERY, INCLUDING AN EXTENDED TROCHANTERIC OSTEOTOMY. SURGEON'S REVISION SURGERY INCLUDED THE REMOVAL FROM PATIENT, ALL OF THE WRIGHT MEDICAL COMPONENTS OF ITS RIGHT HIP. SURGEON'S REVISION

  Patient problems: Pain

  MAUDE report 15313118 ↗
• InjuryApr 6, 2022Break; Break

  ALLEGEDLY, PATIENT WAS REVISED DUE TO IMPLANT FRACTURE - STEM. REVISION NJR NUMBER: (B)(4). SIDE: L. PRIMARY ASA: P1 - FIT AND HEALTHY. PRODUCT: PROCOTYL L BEADED AND HA COATED CUP SIZE 48MM. PRODUCT ID: PHA06258, LOT # 1373809. PRODUCT: RIM-LOCK BIOLOX DELTA CERAMIC LINER 32MM, ID GROUP: C. PRODUCT ID: PHA04506, LOT # 711395438.

  Patient problems: Failure of Implant

  MAUDE report 14021649 ↗
• InjuryFeb 15, 2022Mechanical Problem; Mechanical Problem

  ALLEGEDLY, THE PATIENT WAS COMPLAINING OF PAIN AND CRP LEVELS WERE HIGH, SO WE SUSPECTED INFECTION AND PLANNED TO REMOVE THE TL, BUT AS IT TURNED OUT, THERE WAS NO INFECTION IN THE TEST RESULTS. DURING THE OP, THE NECK COULD NOT BE REMOVED FROM THE STEM NO MATTER WHAT I DID, AND AS A RESULT, THE ENTIRE STEM WAS REMOVED. THE AFFECTED AREA WAS CLEAN AND THERE WAS NO LOOSENING ON THE CUP SIDE. THERE WAS NO EVIDENCE OF BONE ON GROWTH AT THE PROXIMAL PLASMAPHERESIS COATING. (B)(4).

  Patient problems: Pain

  MAUDE report 13535839 ↗
• InjuryFeb 7, 2022Break; Difficult to Remove; Break; 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 13473311 ↗
• InjuryMar 29, 2021Break; Break

  ALLEGEDLY, THE PATIENT WAS REVISED DUE TO FAILURE OF THE MODULAR NECK AT THE NECK/STEM JUNCTION TAPER (FRACTURED NECK). THE REVISION OPERATIVE NOTES ALSO LISTS, "MODERATE METALLOSIS (NO PSEUDOTUMOR)" AS AN INTRAOPERATIVE FINDING.

  Patient problems: Metal Related Pathology

  MAUDE report 11585588 ↗
• InjuryDec 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 11076776 ↗
• InjuryNov 6, 2020Break; Break

  ALLEGEDLY, ON (B)(6) 2020 PATIENT FELT A CRACKING IN THE LEFT HIP JOINT WHICH RESULTED IN A WAY GIVING OF THE LEFT LEG. INITIAL XRAY SHOWED A MODULAR NECK FRACTURE. FIRST INTRODUCTION TOOK PLACE IN (B)(6). PATIENT COULD NOT UNDERGO SURGERY IN (B)(6), SO PATIENT WAS INTRODUCED IN DOMO. BFARM CASE NUMBER: (B)(6). ADDITIONAL INFORMATION RECEIVED ON 10/14/2020 FROM (B)(6) : ADDING EXPLANT DATE.

  Patient problems: No Information

  MAUDE report 10804991 ↗
• InjurySep 29, 2020Break; Break

  ALLEGEDLY, PATIENT WAS REVISED DUE TO MODULAR NECK BROKEN. NECK AND HEAD WERE REVISED. COMPONENT NOT REVISED: PROFEMURE FEMORAL STEM PRODUCT NUMBER : PHA03143, LOT NUMBER: 029814769. ADDITIONAL INFORMATION RECEIVED ON 09/09/2020 FROM BFARM : ADDING CASE NUMBER. BFARM CASE NUMBER: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 10602793 ↗
• InjurySep 10, 2020Break; Break

  ALLEGEDLY, DURING THE SQUAT THE PATIENT FELT A STRONG PAIN IN THE LEFT HIP. THE PATIENT WAS REVISED DUE TO BROKEN NECK.

  Patient problems: No Information

  MAUDE report 10514838 ↗
• InjuryAug 4, 2020Corroded; Corroded

  ALLEGEDLY, PATIENT WAS REVISED DUE TO CORROSION AT THE METAL-METAL JUNCTION BETWEEN THE COBALT-CHROMIUM MODULAR NECK AND THE TITANIUM STEM AND THE METAL DEBRIS AND ION CAST OFF FROM THE COBALT AND CHROMIUM CONSERVE FEMORAL HEAD AND COBALT AND CHROMIUM DYNASTY LINER. MODULAR NECK WAS REMOVED AND CONSERVE FEMORAL HEAD WAS REPLACED WITH A POLYETHYLENE DUAL FEMORAL HEAD.

  Patient problems: No Information

  MAUDE report 10362019 ↗
• InjuryMay 22, 2020Break; Break

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS. LEFT. UPDATE 10/09/2019: INSTRUCTED DR DAVIS THAT THE CURRENT NECK NEED TO COME OUT DUE TO POSSIBLE FAILURE NECK WOULD NOT COME OUT THE INSTRUMENTS THAT WE HAD BOTH DR DAVIS CHUCK TRIED TO EXTRACT IT. I TOLD THEM TO STOP BECAUSE WE COULD BREAK THE EXTRACTING DEVICE FOR GOT TRIALS LINERS SO THEY WASTED ONE STRECKER DUAL MOBILITY LINER WAS USED WITH OUR HEAD.

  Patient problems: No Information

  MAUDE report 10082995 ↗
• InjuryApr 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION COMPONENT NOT REVISED : COTYLE "ANCA" AVEC TROUS A/REVET. HAP 52 PPR67252, LOT V0284973. NOYAU "ANCA FIT?"10 DEG. 52*28 PPR67552, LOT U0265520.

  Patient problems: No Information

  MAUDE report 9922286 ↗
• InjuryMar 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION COMPONENTS NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 54 PPR67254, LOT T07124541. TETE FEMORALE 28 CM 12/14 CERAMIQUE AL2.O3 PPT10252, LOT T10133573. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 12G PPR67610, LOT T07126076. INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE PPR67510, LOT T09133022.

  Patient problems: No Information

  MAUDE report 9904112 ↗
• InjuryMar 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO SEPTIC LOOSENING CODE LINER : 68.13.28-46, LOT 2017592 IS NOT MPO PRODUCT.

  Patient problems: Unspecified Infection

  MAUDE report 9819409 ↗
• InjuryFeb 29, 2020Break; Break

  ALLEGEDLY, PATIENT WAS REVISED DUE TO NECK FRACTURE.

  Patient problems: No Code Available

  MAUDE report 9772464 ↗
• InjuryDec 12, 2019Break; Break

  ALLEGEDLY, NECK FRACTURE AND PROXIMALLY FRACTURED STEM IN INTRAMEDULLARY SITUATION WITH ENDOSTEAL SUPPORT. PERIARTICULAR METALLOSIS. AEMPS REFERENCE NUMBER: (B)(4). UPDATE RECEIVED ON 12/03/2019. PATIENT SUFFERED HIGH LEVELS OF COBALT AND CHROMIUM.

  Patient problems: No Information

  MAUDE report 9460708 ↗
• InjuryJul 27, 2016Break; Break

  ALLEGEDLY, PATIENT IS SUFFERING FROM MOM COMPLICATIONS. (LEFT). ADDITIONAL INFORMATION RECEIVED 04/08/2016: ALLEGEDLY THE PATIENT WAS REVISED DUE TO A NECK FRACTURE AND MOM COMPLICATIONS:ACETABULUM SHOWED SIGNS OF ANTEVERSION, FLUID(LEFT). UPDATED SURGERY INFORMATION (IMPLANT/EXPLANT/OP NOTES), AND PRODUCT (PART NUMBER/LOT NUMBER) INFORMATION.

  Patient problems: Reaction

  MAUDE report 5826400 ↗