PROCOTYL PHA04404Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI M684PHA044041), received between May 30, 2019 and Feb 6, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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.

• InjuryFeb 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION FROM CLINICAL STUDY # (B)(4). PATIENT # (B)(6) REPORTED THE FOLLOWING ADVERSE EVENTS: PAIN AND FUNCTIONAL IMPAIRMENT. THIS ADVERSE EVENT DID NOT END UP IN REVISION SURGERY.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 21324204 ↗
• InjuryJan 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, AFTER THE INITIAL SURGERY ON (B)(6), THE PATIENT UNDERWENT REHABILITATION INCLUDING GAIT TRAINING, BUT COMPLAINED OF PAIN AND HAD DIFFICULTY WALKING, SO AN X-RAY CONFIRMED DISLOCATION. THE PATIENT WAS ABLE TO MANUALLY REPAIR THE DISLOCATION, BUT LATER DISLOCATED AGAIN, SO A REVISION OPERATION WAS PERFORMED TO REPLACE THE NECK, HEAD, AND BIPOLAR CUP, AND THE PATIENT HAS BEEN STABLE SINCE THEN. DOCTOR'S FINDING: THE PATIENT HAD UNDERGONE REHABILITATION AFTER THE INITIAL OPERATION, BUT REPEATED DISLOCATIONS OCCURRED, SO A REVISION OPERATION WAS PERFORMED. WE WOULD LIKE TO REQUEST AN INVESTIGATION TO SEE IF THE DISLOCATION COULD HAVE BEEN CAUSED BY THE PRODUCT. JAPAN-OC00000588.

  Patient problems: Pain

  MAUDE report 21242729 ↗
• InjuryApr 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT UNDERWENT R THR ON (B)(6) 2024 FOLLOWING WHICH THE FEMORAL IMPLANT SUBSIDED AND THE HIP DISLOCATED. PATIENT WAS REVISED ON (B)(6) 2024 WITH A LONGER FEMORAL HEAD. (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19011397 ↗
• InjuryNov 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. STEM/DISLOCATION/SUBLUXATION REVISION NJR NUMBER: 4973583. SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. NON-MPO PRODUCTS: PART ID: 65-6400-50-22 F/M ACET SHELL WITH HA-TCP CALCICOAT - 50MM O.D/ LOT. NUMBER: 60358559/ QTY:1. PART ID: 6415-28-02 ALUMINA INSERT 48-54 X 28/ LOT. NUMBER: 61300387/ QTY:1.

  Patient problems: Bone Fracture(s)

  MAUDE report 15744184 ↗
• InjurySep 2, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, HER OPERATING SURGEON FOUND A FAILURE OF LEFT TOTAL HIP PROSTHESIS SO THE PATIENT HAD TO BE REVISED. COMPONENTS NOT REVISED: DYNASTY® PC SHELL 48MM GROUP B / PRODUCT ID: DSPCGB48 / LOT NO.: 1657397. PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ11 V8DG SHORT NECK / PRODUCT ID: PLSER011 / LOT NO.: 1491759.

  Patient problems: Failure of Implant

  MAUDE report 12418328 ↗
• InjuryOct 16, 2020Material Fragmentation; Device Dislodged or Dislocated

  PATIENT'S WIFE CALLED ON (B)(6) 2020 TO REPORT THAT HER HUSBAND HAD A REVISION SURGERY. ALLEGEDLY, THE PRODUCT WAS DISLODGED BUT THAT THERE WAS METALOSIS. STILL PENDING TO CONFIRM IF THE HIP IMPLANT WAS MANUFACTURED BY MICROPORT OR ANOTHER COMPANY. APPARENTLY, AT THE REVISION THEY USED A MICROPORT PRODUCT.

  Patient problems: No Information

  MAUDE report 10689448 ↗
• InjurySep 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION. IMPLANT WAS REMOVED AND REPLACED. (B)(6).

  Patient problems: No Information

  MAUDE report 10538036 ↗
• InjuryOct 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PAIN SLIGHTLY ELEVATED METAL ION LEVELS, (B)(6) REMOVED THE NECK, HEAD AND DUAL MOBILITY LINER. HE REPLACED THE VV8 NECK, BIOLOX 28MM HEAD WITH A SHORT TI STRAIGHT NECK AND BIOLOX 28MM LONG.

  Patient problems: Pain; Reaction

  MAUDE report 9203752 ↗
• InjuryMay 30, 2019Unstable; Unstable

  DURING INVESTIGATION, IT WAS FOUND THAT THE PATIENT HAD A PREVIOUS REVISION SURGERY. ALLEGEDLY THE PATIENT WAS REVISED DUE TO INSTABILITY (LEFT). ONLY THE ACETABULAR COMPONENT (NOT MICROPORT PRODUCT), FEMORAL HEAD AND MODULAR NECK WERE EXCHANGED. THE PROFEMUR® Z STEM PLASMA SPRAYED, PHA00266, LOT: 018512517 FROM (B)(6) 2008 SURGERY REMAINS IN PLACE. FIRST REVISION SURGERY CAPTURED UNDER: (B)(4).

  Patient problems: No Information

  MAUDE report 8656161 ↗