Profemur PLS0R411Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684PLS0R4111), received between Jul 15, 2021 and Oct 11, 2022 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2022Difficult to Remove; Unstable; Device Dislodged or Dislocated; Difficult to Remove; Unstable; Device Dislodged or Dislocated

  ALLEGEDLY, ON OR ABOUT APRIL 30,204 PATIENT HAD A PROFEMUR TOTAL HIP SYSTEM IMPLANTED IN HER RIGHT HIP. ON OR ABOUT (B)(6) 2019 PATIENT REPORTED FOR REVISION SURGERY DUE TO ELEVATED COBAL AND CHROMIUN LEVELS, PAIN AND EVIDENCE OF A PSEUDOTUMOR. PATIENT'S FIRST REVISION WAS NECESSARY BECAUSE THE DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION. IT WAS DISCOVERED CORROSION OF THE PROFEMUR COCR MODULAR NECK WHERE IT SEATED IN THE POCKET OF THE MODULAR STEM. THE IMPLANTED NECK AND HEAD WERE REVISED. AFTER THE REVISION SURGERY PATIENT REPORTED AT LEAST 3 DISLOCATIONS. THE PREVIOUS EVENTS WERE CAPTURED UNDER MICROPORT ORTHOPEDICS GROUP NUMBER: 20060165. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022: ALLEGEDLY, ON OR ABOUT (B)(6) 2021, PATIENT REPORTER FOR A REVISION SURGERY OF THE RIGHT TOTAL HIP ARTHROPLASTY, REVISION OF BOTH THE ACETABULAR AND FEMORAL COMPONENTS. SURGEON RECOMMENDED THIS SECOND REVISION SURGERY DUE TO RECURRENT INSTABILITY WITH DISLOCATIONS. DURING REVISION SURGERY, SURGEON DETERMINED THE ONLY WAY TO SAFELY REMOVE THE MODULAR STEM WAS TO PERFORM AN EXTENDED TROCHANTERIC OSTEOTOMY(ETO), WHICH REQUIRED FOUR DALL MILES CABLES WITH THE USE OF A 240 MM REVISION STEM.

  Patient problems: Metal Related Pathology; Osteopenia/ Osteoporosis

  MAUDE report 15583485 ↗
• InjuryJul 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT REVISED DUE TO COPIOUS AMOUNT OF BLACK DISCOLORED TISSUE, BLACK DISCOLORATION OF THE JOINT CAPSULE CONSISTENT WITH METALLOSIS AND DISLOCATION. (LEFT HIP)

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12178681 ↗