PROCOTYL PHA04408Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI M684PHA044081), received between Aug 4, 2020 and Jun 10, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. SRNJR NUMBER: (B)(6), SIDE: R, GENDER: F. NON-REVISED PRODUCTS: PRODUCT ID: PPPSQH48 PROCOTYL® P PS SHELL QUAD/ LOT NO.: 2007776/ QTY: 1.

  Patient problems: Bone Fracture(s)

  MAUDE report 22176058 ↗
• InjuryJan 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION. SRNJR NUMBER: (B)(6). SIDE: R. GENDER: F.

  Patient problems: Insufficient Information

  MAUDE report 21209637 ↗
• InjuryFeb 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, DISLOCATION/SUBLUXATION SIDE: L REVISION NJR: (B)(4). GENDER: F EXPLANTED: FEMORAL STEM, ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER.

  Patient problems: Insufficient Information

  MAUDE report 18760111 ↗
• InjuryMar 1, 2022Break

  ALLEGEDLY, PATIENT WAS EX DOMO (PROF R IMPLANTATION IN ANOTHER HOSPITAL). PROSTHESIS PSEUDO- ARTHRITIC, BROKEN STEM BELOW PROXIMAL PART. REGARDING A LOW GRADE INFECT AS DIFFERENTIAL DIAGNOSIS, STEM AND CUP EXPLANTED IN (B)(6) HOSPITAL. BFARM CASE NUMBER: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 13640098 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS COMPONENT NOT REVISED: 1- PART ID: PHA06256, PROCOTYL L BEADED AND HA COATED CUP SIZE 46MM, LOT:1536726, QTY:1. REVISION NJR NUMBER: (B)(4), SIDE:R, PRIMARY ASA: P1 - FIT AND HEALTHY.

  Patient problems: Metal Related Pathology

  MAUDE report 13414859 ↗
• InjuryDec 16, 2021Use of Device Problem; Use of Device Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO HEAD/SOCKET MISMATCH - HEAD. REVISION NJR NUMBER: (B)(6). SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Insufficient Information

  MAUDE report 13017578 ↗
• InjuryAug 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION.

  Patient problems: Insufficient Information

  MAUDE report 12388662 ↗
• InjuryApr 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION. REVISION NJR NUMBER: (B)(4). SIDE:L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENT NOT REVISED: PROFEMUR XM STEM SIZE 0 / PRODUCT ID: PHA06000 / LOT NO.: 1659776. PROFEMUR® NECK NEUTRAL SHORT / PRODUCT ID: PHA01202 / LOT NO.: 1666220. PROFEMUR® XM DISTAL CENTRALIZER / PRODUCT ID: PRXMDC01 / LOT NO.: 15571341622616. MHRA REFERENCE NO: (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11659546 ↗
• InjuryAug 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, WOUND INFECTION IN THE PATIENT RIGHT HIP WAS DETECTED. THE PATIENT HAD A MEDICAL INTERVENTION FOR WOUND DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 10363106 ↗