PROFEMUR® PRTL0024Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI M684PRTL00241), received between Jun 26, 2019 and Jun 18, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Corroded” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2024Corroded; Corroded

  ALLEGEDLY, PATIENT UNDERWENT A LEFT-SIDED TOTAL HIP ARTHROPLASTY ON (B)(6) 2020. ON OR ABOUT (B)(6) 2024, THE PATIENT REPORTED TO THE SURGEON PAIN, DEBILITATING LACK OF MOBILITY, AND HE RECOMMEND REVISION SURGERY BECAUSE THE DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION. THE MODULAR NECK SLOT AND FEMORAL NECK DISTAL END HAS CORROSIVE CHANGES AND METAL DEBRIS CONSISTENT WITH COCR DAMAGE. NON REVISED PRODUCTS: PRODUCT ID: P2LXSD36 PRIME A-CLASS® XLPE STANDARD / LOT NO.: 1835920 / QTY: 1 PRODUCT ID: P3SBQD54 PRIME BIOFOAM QUAD SHELL / LOT NO.: 1834699 / QTY: 1.

  Patient problems: Insufficient Information

  MAUDE report 19559318 ↗
• InjurySep 25, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WHO UNDERWENT SUPERPATH PROSTHESIS ON (B)(6) DISLOCATED ON (B)(6) AND STEM AND CHANGEABLE NECK WERE DISLOCATED DURING MANUAL HEALING, AND REVISION WAS PERFORMED ON (B)(6) IN AN OPEN SURGERY. PHYSICIAN'S FINDINGS: WHETHER THERE ARE PREVIOUS REPORTS OF STEM AND CHANGEABLE NECK DISASSEMBLY. PRODUCT PROBLEM NOTED. CAUSED BURDEN TO THE PATIENT. REQUEST TO DETERMINE THE CAUSE OF THE PROBLEM. THE ABOVE REQUESTS HAVE BEEN RECEIVED. REPORTING PARTY'S FINDINGS AND STATUS OF RESPONSE: IT IS NOT USUAL FOR THE STEM AND CHANGEABLE NECK TO COME OFF BY MANUAL MANIPULATION. (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17806745 ↗
• InjurySep 14, 2022Corroded; Corroded

  ALLEGEDLY, ON (B)(6) 2012, PATIENT HAD A WRIGHT MEDICAL ARTIFICIAL HIP IMPLANTED IN THE RIGHT SIDE OF HIS BODY. ON OR ABOUT (B)(6) 2020 PATIENT WAS TOLD THAT HE SUFFERED A BROKEN SCREW HOLDING THE DYNASTY CUP, LEADING TO LOOSENING OF THE CUP AND PAIN IN HIS RIGHT HIP, AND THAT IT WAS ADVISABLE THAT HE UNDERGO SURGERY TO REMOVE THE DYNASTY CUP AND SCREWS AND REPLACE AND REFIX THE CUP AND FIXATION SCREWS (IT IS NOT INDICATED WHICH SCREW WAS BROKEN SINCE PATIENT HAD 3 SCREWS IMPLANTED. ALSO, IT HAS NOT BEEN INDICATED WHICH CUP AND SCREWS WERE USED TO REPLACE THE DYNASTY CUP AND SCREWS). THIS EVENT IS CAPTURED UNDER MICROPORT ORTHOPEDICS INCIDENT GROUP NUMBER: (B)(4). ON OR ABOUT (B)(6) 2022, PATIENT SUFFERED A RIGHT HIP IMPLANT DISLOCATION. BY (B)(6) 2022, PATIENT DEVELOPED SYMPTOMS OF, AMONG OTHERS, LOW BACK PAIN, DEVELOPMENT OF A CYST ON HIS RIGHT THIGH, IN ADDITION TO SUFFERING RECENT RIGHT HIP DISLOCATION. PATIENT'S ORTHOPEDIC SURGEON AFTER THE (B)(6) 2022 DISLOCATION, INFORMED PATIENT THAT IN HIS MEDICAL JUDGMENT IT WAS ADVISABLE TO UNDERGO A RIGHT HIP REVISION SURGERY TO REMOVE THE PROFEMUR® HIP SYSTEM, INCLUDING THE PROFEMUR® PLUS COCR MODULAR NECK AND THE PROFEMUR® TL STEM, AN

  Patient problems: Metal Related Pathology; Osteopenia/ Osteoporosis; Pain

  MAUDE report 15419082 ↗
• InjuryAug 29, 2022Corroded; Material Frayed; Corroded; Material Frayed

  ALLEGEDLY, ON (B)(6), 2012, 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). PATIENT'S (B)(6)2012, HIP IMPLANT SURGERY WAS PERFORMED AT THE HOSPITAL FOR JOINT DISEASES, NEW YORK, NEW YORK. AFTER HIS INITIAL RECOVERY FROM THE (B)(6) 2012, HIP SURGERY, FOR SEVERAL YEARS PATIENT'S WRIGHT MEDICAL ARTIFICIAL HIP PERFORMED AS EXPECTED, AND THE PAIN AND DISABILITY PATIENT HAD EXPERIENCED IN HIS RIGHT HIP PRIOR TO HIS (B)(6) 2012, HIP REPLACEMENT SURGERY HAD BEEN SUBSTANTIALLY RELIEVED. LATE IN THE YEAR 2019 PATIENT DEVELOPED ADVERSE SYMPTOMS INCLUDING, BUT NOT LIMITED TO, PROGRESSIVELY WORSENING PAIN IN AND AROUND HIS RIGHT HIP JOINT. PATIENT'S ORTHOPEDIC SURGEON, SUBSEQUENTLY, IN THE YEAR 2021, INFORMED PATIENT THAT IN HIS MEDICAL JUDGMENT IT WAS ADVISABLE TO UNDERGO A RIGHT HIP REVISION SURGERY TO REMOVE THE PROFEMUR® HIP SYSTEM, INCLUDING THE PROFEMUR® PLUS COCR MODULAR NECK AND THE PROFEMUR® TL FEMORAL STEM, AND REPLACE IT WITH A HIP STEM SYSTEM OF A DIFFERENT MEDICAL DEVICE MANUFACTURER, ZIMMER-BIOMET. SURGEON ALSO INFORMED PATIENT THAT IT WOULD BE MEDICALLY NECESSARY TO REMOVE AND REPLACE THE

  Patient problems: Neuropathy; Pain

  MAUDE report 15312880 ↗
• InjuryJul 15, 2021Corroded; Corroded

  ALLEGEDLY, PATIENT REVISED DUE TO EVIDENCE OF PSEUDOTUMOR AND CORROSION. CHANGES ON THE FEMALE SIDE OF THE TAPER AND ON THE MALE SIDE TO A LESSER DEGREE (RIGHT HIP).

  Patient problems: Inflammation

  MAUDE report 12178716 ↗
• InjuryJan 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE STEM. REVISION NJR NUMBER: (B)(6). SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED: PROCOTYL L BEADED AND HA COATED CUP SIZE 52MM / PRODUCT ID: PHA06262 / LOT NO: 1436841. RIM-LOCK BIOLOX DELTA CERAMIC LINER 36MM ID GROUP E / PRODUCT ID: PHA04510 / LOT NO: 1459956. (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11151939 ↗
• InjuryOct 8, 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: P1 - FIT AND HEALTHY. COMPONENTS NOT REVISED: PROCOTYL L BEADED AND HA COATED CUP SIZE 54MM PRODUCT NUMBER: PHA06264 LOT NUMBER: 118717906. RIM-LOCK BIOLOX DELTA CERAMIC LINER 36MM ID GROUP E: PRODUCT NUMBER : PHA04510 LOT NUMBER: 069896421. ADDITIONAL INFORMATION RECEIVED ON 10/20/2020 FROM (B)(6): ADDING LOT NUMBERS. MHRA REFERENCE NO: (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10648138 ↗
• InjuryFeb 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, THE DEVICE FAILED DUE TO METAL DEBRIS CORROSION AND RESULTANT METAL IONS, DUE TO THE METAL ON METAL DESIGN BETWEEN THE ARTICULATING SURFACES, CAUSING CONTINUING AND OTHERWISE IRREVERSIBLE PHYSICAL INJURY TO THE PATIENT.

  Patient problems: Pain

  MAUDE report 9708365 ↗
• InjuryJun 26, 2019Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING STEM. REVISION NJR NUMBER (B)(4). SIDE: R. PRIMARY ASA: P2-MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 8736683 ↗