PROCOTYL PHA06214Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684PHA062141), received between Jan 30, 2020 and Mar 26, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSERT ASEPTIC LOOSENING COMPONENTS NOT REVISED: PROFEMUR® PRESERVE STEM SIZE 9 PRPR0009 1621391.

  Patient problems: No Information

  MAUDE report 9884532 ↗
• InjuryFeb 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 9720918 ↗
• InjuryFeb 17, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO SEPTIC LOOSENING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9717859 ↗
• InjuryJan 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN WITHOUT LOOSENING. PRODUCT NOT REVISED: ACETABULAR CUP "PROCOTYL® L" BEADED COATED S.54 GROUP E, CATALOG # PHA0-6214, LOT # 10746483501, QTY 1. RIM-LOCK BIOLOX DELTA CERAMIC LINER 36 GROUP E, CATALOG # PHA04510, LOT # X10473186, QTY 1.

  Patient problems: Pain

  MAUDE report 9648491 ↗