PROFEMUR® PRTLS027Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684PRTLS0271), received between Nov 26, 2020 and Apr 12, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION. REVISION NJR NUMBER: 4537592. SIDE: L.. PRIMARY ASA: P1 - FIT AND HEALTHY.

  Patient problems: Insufficient Information

  MAUDE report 16725795 ↗
• InjuryMay 4, 2022Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, ON (B)(6) 2021, THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY, SYNOVECTOMY, HIP JOINT RELEASE, AND ACETABULAR BASE AUTOGENOUS BONE GRAFTING IN THE HOSPITAL. THE PATIENT RECOVERED AND WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2022 (7 MONTHS AFTER OPERATION), THE PATIENT HAD PAIN IN HIS RIGHT THIGH FOR HALF A YEAR AND WENT TO THE HOSPITAL FOR EXAMINATION. ON (B)(6) 2022, THE DOCTOR DIAGNOSED THE PATIENT AS POSTOPERATIVE IMPLANT LOOSENING. DURING THIS TIME, THE DOCTOR MADE A THOROUGH EXAMINATION OF THE PATIENT. ON (B)(6) 2022, THE DOCTOR PERFORMED THE REVISION OF THE RIGHT TOTAL ARTIFICIAL HIP IN THE OPERATING ROOM. THE PAIN DISAPPEARED AFTER OPERATION, AND THE PATIENT RECOVERED AND WAS DISCHARGED FROM HOSPITAL.

  Patient problems: Pain

  MAUDE report 14277906 ↗
• InjuryNov 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT DISLOCATED THE DAY AFTER SURGERY. THE SURGEON FELT THAT THE REASON FOR THE DISLOCATION WAS A ''LACK OF TENSION'' , OR OFFSET. THIS WAS RESOLVED WITH A BIGGER STEM, CREATING MORE OFFSET, AND USING THE VARUS OPTION, PLUS A LONGER HEAD. THE SURGEON PUTS THIS DOWN TO SURGEON ERROR. ALSO, THE DIGITAL TEMPLATING SYSTEM WAS NOT AVAILABLE BEFORE THE OPERATION WITH FURTHER COMPLICATED MATTERS. ADDITIONAL INFORMATION RECEIVED ON 11/16/2020: ADDING COMPONENTS NOT REVISED, PATIENT INFORMATION AND INCIDENT CODE: COMPONENTS NOT REVISED: PROCOTYL L BEADED AND HA COATED CUP SIZE 54MM / PRODUCT ID: PHA06264 / LOT NO: 1802480. RIM-LOCK BIOLOX DELTA CERAMIC LINER 36MM ID GROUP E / PRODUCT ID: PHA04510 / LOT NO: 1819068.

  Patient problems: No Information

  MAUDE report 10911433 ↗