PROFEMUR® PRTL0025Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684PRTL00251), received between Mar 10, 2020 and Mar 7, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Corroded” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Corroded; Corroded

  ALLEGEDLY, DOCTOR RECOMMENDED THE REVISION SURGERY AFTER PLAINTIFF PRESENTED WITH PROGRESSIVE RIGHT HIP PAIN, ELEVATED ION LEVELS, METALLOSIS CHANGES AROUND THE FEMORAL NECK AND SURROUNDING SOFT TISSUES AROUND THE PROXIMAL FEMUR, ADVERSE LOCAL TISSUE REACTION AND LACK OF MOBILITY. THE REVISION WAS NECESSARY BECAUSE THE DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION OF THE DEVICE. PRODUCTS NOT SPECIFIED THEY WERE REVISED: PRODUCT ID: DBFPGD52 DYNASTY® BF SHELL PRIMARY 52MM GROUP D, LOT: 1684715, QTY:1.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 21548583 ↗
• InjuryMay 12, 2022Material Discolored

  ALLEGEDLY, THE PATIENT HAS BEEN SUFFERING MODERATE PAIN, AND THE IMPLANTS WERE REVISED FOR METALLOSIS, ACCORDING TO THE SURGEON. THE MODULAR NECK TRUNION (FITTING IN TO THE STEM POCKET) WAS NOTICEABLY "BLACKENED". ALL IMPLANTS WERE REMOVED, AND REPLACED WITH A THR CEMENT SPACER. UNFORTUNATELY IT WASN'T POSSIBLE TO REMOVE THE LINER FROM THE PROCOTYL L SHELL, SO I CANT PROVIDE THE LOT NUMBER FOR THE BIOLOX LINER.

  Patient problems: Metal Related Pathology; Pain; Unspecified Infection

  MAUDE report 14380060 ↗
• InjuryFeb 15, 2022Mechanical Problem; Loss of Osseointegration; Mechanical Problem; Loss of Osseointegration

  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 13534768 ↗
• InjuryNov 8, 2021Appropriate Device Problem Term/Code Not Available

  SAE# (B)(4). ALLEGEDLY, THE PATIENT STARTED HAVING LT HIP PAIN 3 WEEKS AFTER SURGERY. MULTIPLE ATTEMPTS TO RELIEF THE PAIN WITH CORTICOSTEROID INJECTIONS INTRA-ARTICULAR WITH NO SUCCESS. THE PATIENT UNDERWENT A SURGICAL INTERVENTION FOR RELEASE OF THE PSOAS TENDON ON (B)(6) 2018. THE PAIN AND WEAKNESS IN THE LEFT THIGH IS STILL PERSISTENT. ADDITIONAL INFORMATION FROM CLINICAL RECEIVED ON (B)(6) 2021 CONFIRMING THAT COMPONENTS WERE NOT REVISED.

  Patient problems: Pain

  MAUDE report 12771850 ↗
• 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 12615224 ↗
• InjuryMar 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, SUBJECT WAS SEEN IN EMERGENCY ROOM WITH RIGHT HIP PAIN FOR 2 WEEKS, CRUNCHING WITH MOTION AND DIFFICULTY AMBULATING. LINER FRACTURE WAS CONFIRMED BY X RAY AND CT OF THE HIP. SUBJECT HAD A REVISION AND REMOVAL OF THE ORIGINAL ACETABULAR, LINER, MODULAR NECK AND FEMORAL HEAD AND WAS DISCHARGED ON (B)(6) 2015.

  Patient problems: Pain

  MAUDE report 9813778 ↗