PROCOTYL® PRIME P3LELB32Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684P3LELB321), received between Jul 16, 2019 and Jul 16, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2019Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible

  ALLEGEDLY PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. TWO WEEKS AFTER THE OPERATION, THE PATIENT POINTED OUT THAT "THE RATTLE NOISE OCCURS IN THE BODY", AND THE SOUND DISAPPEARED A FEW DAYS LATER, BUT WHEN CT WAS TAKEN, THE 32 MM HEAD WAS ACETABULAR. BECAUSE IT WAS AT A POSITION OFFSET FROM THE LID CUP, IT IS PRESUMED THAT THE POLYETHYLENE LINER WAS LIKELY TO BE DISLOCATED, AND DAY 21 POLY LINER REMOVAL + REPLACEMENT SURGERY WAS PERFORMED.

  Patient problems: No Information

  MAUDE report 8796033 ↗