PROCOTYL PHA04412Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI M684PHA044121), received between Jul 21, 2021 and Jan 26, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Device Dislodged or Dislocated; Insufficient Device Problem Information

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

  Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176563 ↗
• InjuryFeb 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Insufficient Information

  MAUDE report 18796564 ↗
• InjuryJan 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Metal Related Pathology

  MAUDE report 16263273 ↗
• InjuryJan 19, 2023Device 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. PRODUCT NO REVISED: PRODUCT ID: PHAS5506, PROFEMUR L CLASSIC FIXED NECK SIZE 3, LOT: 1783114, QTY: 1.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16207293 ↗
• InjuryAug 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT UNDERWENT LEFT THR ON (B)(6) 2022, REVISED ON (B)(6) 2022 DUE TO DISLOCATION. REPLACED WITH LINEAGE/TRASCEND FEMORAL HEAD AND ANOTHER MANUFACTURER'S ACETABULAR SHELL. (B)(6). (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 15254721 ↗
• InjuryFeb 7, 2022Loosening of Implant Not Related to Bone-Ingrowth

  ALLEGEDLY, THE NECK AND HEAD WERE REPLACED FOR LEG LENGTH CORRECTION. ADDITIONALLY, RE-SUBSTITUTION OF CUP DUE TO LOOSENING OF ANOTHER COMPANY'S CUP. MPO'S TL SIZE 1 STEM SIDE WAS FINE. (B)(4).

  Patient problems: Unequal Limb Length

  MAUDE report 13472273 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS REVISION NJR NUMBER: (B)(4), SIDE:R, PRIMARY ASA: P1 - FIT AND HEALTHY. THE FOLLOWING IMPLANTS ARE NOT MPO: PARTID: DURALOC OPTION CUP HYDROXYAPATITE 58MM, LOT#2302042, QTY:1; PARTID: DURALOC OPTION ALUMINA CERAMIC LINERS 32/58 OR 60, LOT#2997376, QTY:1.

  Patient problems: Metal Related Pathology

  MAUDE report 13403008 ↗
• InjuryDec 7, 2021Break; Fracture; Break

  ALLEGEDLY, PATIENT EXPERIENCED A SUDDEN ONSET OF PAIN IN THE HIP JOINT WITH SUBSEQUENT BUCKLING OF THE LEG DURING NORMAL WALKING THE PREVIOUS DAY. RADIOLOGICAL EXAMINATION REVEALED A CONE FRACTURE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 12957500 ↗
• InjurySep 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION. REVISION NJR NUMBER: (B)(4), SIDE:R, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

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

  MAUDE report 12451123 ↗
• InjuryJul 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, THERE WAS ANTERIOR DISLOCATION POSTOPERATIVELY.

  Patient problems: Insufficient Information

  MAUDE report 12204449 ↗