PROCOTYL PHA04422Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684PHA044221), received between Oct 8, 2020 and Apr 12, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 5053707, SIDE: R, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Unspecified Infection

  MAUDE report 16726246 ↗
• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED : PROCOTYL L BEADED AND HA COATED CUP SIZE 56MM, PRODUCT NUMBER: PHA06266, LOT NUMBER: 1816180. PROFEMUR TL CLASSIC FIXED NECK SIZE 7 PRODUCT NUMBER: PRTLS027, LOT NUMBER: 1832175, MHRA REFERENCE NO: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11301192 ↗
• InjuryOct 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(6). SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED : PROCOTYL L BEADED AND HA COATED CUP SIZE 58MM, PRODUCT NUMBER : PHA06268, LOT NUMBER: 1642834. PROFEMUR TL CLASSIC FIXED NECK SIZE 8, PRODUCT NUMBER: PRTLS028, LOT NUMBER: 1809952.

  Patient problems: Unspecified Infection

  MAUDE report 10648710 ↗