Profemur PLS0S413Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684PLS0S4131), received between Mar 24, 2020 and Jan 11, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2024Corroded; Corroded

  ALLEGEDLY, PAIN AROUND THE LEFT HIP JOINT. LABORATORY TEST RESULT OBTAINED ON (B)(6) AND (B)(6) 2022 INDICATE ELEVATED BLOOD COBALT LEVELS. THE IMPLANTS WERE CORRODED AT THE NECK-STEM JUNCTION. NON-MPO PRODUCTS: ZIMMER BIOMET PIN STEINMAN THREAD 3/16IN LOT 62404689.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18494964 ↗
• InjuryJan 26, 2021Device Dislodged or Dislocated

  ALLEGEDLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISLOCATION, METAL DEBRIS WITH PSEUDO-TUMOR FORMATION AND LEG LENGTH DISCREPANCY. COMPONENT NOT REVISED: DSPCGC50 DYNASTY® PC SHELL 50MM GROUP C LOT: 129999843.

  Patient problems: Unequal Limb Length

  MAUDE report 11230205 ↗
• InjuryMar 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY , PATIENT REVISED DUE TO UNKNOWN FAILURE.

  Patient problems: No Information

  MAUDE report 9874155 ↗