PROCOTYL PHA04406Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI M684PHA044061), received between Jun 24, 2019 and Feb 6, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 12 most recent of 12 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)(6): PATIENT #65 REPORTED THE FOLLOWING ADVERSE EVENTS: PAIN. THIS ADVERSE EVENT DID NOT END UP IN REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 21324418 ↗
• InjuryFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, DISLOCATION/SUBLUXATION SIDE: L REVISION NJR: 4099123 GENDER: F EXPLANTED: ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER.

  Patient problems: Insufficient Information

  MAUDE report 18793314 ↗
• InjuryFeb 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, DISLOCATION/SUBLUXATION, SIDE: R, REVISION NJR: 4170729, GENDER: F, EXPLANTED: ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER (ONLY THE HEAD IS AN MPO COMPONENT).

  Patient problems: Insufficient Information

  MAUDE report 18750361 ↗
• InjuryNov 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, TROUBLE OCCURRENCE DURING BEDSIDE REHABILITATION, AN ABNORMALITY WAS NOTICED AND CUP DISLOCATION WAS CONFIRMED BY RADIOGRAPHY. DURING THE HEALING PROCESS, THE NECK WAS ALSO DISLOCATED, AND THE PATIENT UNDERWENT REVISION. DOCTOR'S FINDING: THE PATIENT ORIGINALLY HAD A STANDING ACETABULUM AND PROBLEM WAS PROGRESSING, AND WHILE THE DISLOCATION WAS EXPECTED, THE FACT THAT THE NECK WAS DISLOCATED WAS NOT. THE PATIENT REQUESTED AN INVESTIGATION. ACCORDING TO THE X-RAYS, THE NECK AND THE STEM WERE DISLOCATED, THIS SHOULD NOT HAVE HAPPENED, SINCE THESE DEVICES MUST BE FIXED, SO IT IS PRESUMED THAT THESE COMPONENTS WERE DISSOCIATED FROM EACH OTHER. JAPAN (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15743813 ↗
• InjuryJan 4, 2022Incomplete or Missing Packaging; Incomplete or Missing Packaging

  ALLEGEDLY, AFTER OPENING THE CARTON FOR THE FEMORAL HEAD (REF: (B)(4), LOT:1815693), THE STERILE PACKAGING FOR REF: (B)(4), LOT:1815693 WAS FOUND. AFTER OPENING THE STERILE PACKAGING, THE BIPOLAR SHELL ((B)(4), LOT 1777440) WAS CONTAINED WITHIN THE STERILE PACKAGING LABELED AS THE FEMORAL HEAD. THE SURGERY WAS COMPLETED, BUT WAS DELAYED BY AN HOUR.

  Patient problems: Insufficient Information

  MAUDE report 13153658 ↗
• InjuryDec 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, ITEM IMPLANTED ON (B)(6) 2021 WITHOUT INCIDENT, PATIENT PRESENTED AT EMERGENCY ROOM ON (B)(6) 2021 WITH DISLOCATION OF HEAD/LINER CONSTRUCT FORM SHELL/LINER. CLOSED REDUCTION WAS ATTEMPTED AND UNSUCCESSFUL. PATIENT WAS REFERRED TO (B)(6). REVISING SURGEON DECIDED REMOVAL OF ALL IMPLANTS WAS IN BEST INTEREST OF PATIENT. COMPONENTS SUCCESSFULLY EXPLANTED ON (B)(6) 2021. A SALES REPRESENTATIVE WAS PRESENT AT THE PROCESS. PATIENT SUFFERING FROM DEMENTIA AND NON-AMBULATORY.

  Patient problems: Insufficient Information

  MAUDE report 13101586 ↗
• InjuryFeb 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT KEEPS DISLOCATING. (3 TIMES SINCE 12/19). LINER WAS SWAPPED OUT FOR A 32MM LINER.

  Patient problems: Joint Dislocation

  MAUDE report 11263080 ↗
• InjuryJul 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION+BONE FRACTURE. COMPONENTS NOT REVISED: (B)(4) COTYLE "ANCA FIT?" SANS TROUS A/REVET. HAP 52 LOT U1088757. (B)(4) TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 13D LOT 098634518. (B)(4) INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE LOT U11145690.

  Patient problems: No Information

  MAUDE report 10353320 ↗
• InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT'S WOUND IS STILL DRAINING AND GROIN PAIN IN HIS RIGHT HIP. HEAD, NECK, LINER AND DUAL MOBILITY WERE SWAPPED OUT FOR A NEW ONES. PREVIOUS REVISION CAPTURED UNDER THE INCIDENT GROUP: 20070040.

  Patient problems: Fluid Discharge; Paresis

  MAUDE report 10339711 ↗
• InjuryJul 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY PATIENT HAS DISLOCATED 5 TIMES SINCE LAST SURGERY, THE NECK, HEAD, AND LINER WERE REMOVED. THE SURGEON LENGTHENED THE NECK AND PUT IN A HOODED 15 DEGREE LINER ALONG WITH A DELTA HEAD 36MM WITH A LONG NECK SLEEVE. THE PATIENT HAD A PREVIOUS REVISION FOR MOM, INCIDENT GROUP (B)(6) AND A SECOND REVISION FOR INFECTION, INCIDENT GROUP (B)(6). ITEMS NOT REVISED: DYNASTY BIOFOAM SHELL DSBFGG60 LOT 079859623. CANCELLOUS SCREW 18080304 LOT 058864570. CANCELLOUS SCREW 18080304 LOT 058608048. CANCELLOUS SCREW 18080301 LOT 099934159. PROFEMUR PLASMA Z STEM PHA00270 LOT 067445032.

  Patient problems: No Information

  MAUDE report 10284722 ↗
• InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO INFECTION. HIP WAS WASHED OUT , HEAD WAS REMOVED AS WELL AS A CABLE FORM A PREVIOUS SURGERY. (PROBABLY FROM A PAST FRACTURE OF THE FEMUR) CULTURES TAKEN.

  Patient problems: Unspecified Infection

  MAUDE report 8804358 ↗
• InjuryJun 24, 2019Naturally Worn; Naturally Worn

  ALLEGEDLY, THE INSERT DETERIORATED BY THE FRICTION OF THE FEMORAL NECK.

  Patient problems: Loss of Range of Motion

  MAUDE report 8727863 ↗