Profemur PLS0R413Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684PLS0R4131), received between Aug 29, 2022 and Mar 30, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Corroded” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2023Corroded; Material Frayed; Insufficient Device Problem Information; Corroded; Material Frayed; Insufficient Device Problem Information

  ALLEGEDLY, QS DIRECTOR RECEIVED A CALL FROM A PATIENT, FOR SOME REASON PATIENT HAS BEEN EXPERIENCING PAIN. ADDITIONAL INFORMATION ON DATE 05/10/2023: ALLEGEDLY, THE PATIENT HAS PAIN, AND HAS BEEN REVISED FROM THE COCR NECK TO THE TI NECK. PATIENT STATED HAD FRETTING, BUT HER COCR LEVELS WERE NOT TOO ELEVATED BASED ON WHAT THE DOCTOR TOLD. ADDITIONAL INFORMATION ON DATE 08/23/2023: ALLEGEDLY, DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION. REVISION COULD NOT BE CONFIRMED: PART ID: DSPCGB48 DYNASTY® PC SHELL 48MM GROUP B, LOT: 1417042, QTY: (B)(4).

  Patient problems: Pain

  MAUDE report 16644767 ↗
• InjuryMar 29, 2023Corroded; Material Frayed; Insufficient Device Problem Information; Corroded; Material Frayed; Insufficient Device Problem Information

  ALLEGEDLY, QS DIRECTOR RECEIVED A CALL FROM A PATIENT, FOR SOME REASON PATIENT HAS BEEN EXPERIENCING PAIN. ADDITIONAL INFORMATION ON DATE 05/10/2023 ALLEGEDLY, THE PATIENT HAS PAIN, AND HAS BEEN REVISED FROM THE COCR NECK TO THE TI NECK. PATIENT STATED HAD FRETTING, BUT HER COCR LEVELS WERE NOT TOO ELEVATED BASED ON WHAT THE DOCTOR TOLD. PRODUCTS NOT REVISED: DSPCGB48 PRODUCT ID: DYNASTY PC SHELL LOT# 1417042 QTY: (B)(4) DLXPGB28 PRODUCT ID: DYNASTY POLY LINER LOT# 1567743 QTY: (B)(4) PLS0R413 PRODUCT ID: PROFEMUR RENAISSANCE STEM LOT# 1550698 QTY:(B)(4).

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 16637606 ↗
• InjuryAug 29, 2022Difficult to Remove; Difficult to Remove

  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 SU

  Patient problems: Failure of Implant

  MAUDE report 15313434 ↗