PROCOTYL PHA06220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684PHA062201), received between Nov 22, 2019 and Jul 6, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY BREAKAGE/SPLINTERING OF THE LINER (RIM SPLINTRED, CERAMIC PARTICLES WITHIN THE TISSUE). X-RAY BEFORE SURGERY SHOWED CERAMIC PARTICLES NEAR FEMORAL NECK. THE PATIENT WAS REVISED PRIMARILY DUE TO A A LATE LOW-GRADE INFECTION (STAPH. CAPRAE), NOT DUE TO THE CERAMIC BREAKAGE. INTRAOPERATIVELY, CERAMIC INSERT SHOWED SMALL LESION ON RIM AT THREE PLACES. SOME CERAMIC PARTICLES REMOVED DURING EXPLANTATION. CUP AND STEM WERE WELL FIXED IN BONE. METALBACK DAMAGED DURING EXPLANTATION. (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 10233797 ↗
• InjuryNov 22, 2019Loss of Osseointegration; Loss of Osseointegration

  (B)(4). ALLEGEDLY, REVISION SURGERY OF THE LEFT HIP DUE TO EARLY PROCOTYL L CUP LOOSENING AND MIGRATION. REMOVAL OF LOOSED ACETABULAR COMPONENT (PROCOTYL L), THREADED CUP IMPLANTATION, REPLACEMENT OF MODULAR NECK AND HEAD (DUE TO INFECTION RISK REDUCTION). ADDITIONAL INFORMATION RECEIVED ON 10/09/2020 FROM CLINICAL DEPARTMENT : ADDING LOT NUMBERS OF THE PRODUCTS , UPDATING CUSTOMER AND DOCTOR INFORMATION.

  Patient problems: No Information

  MAUDE report 9365819 ↗