PROCOTYL PHA04402Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI M684PHA044021), received between Mar 23, 2020 and Jan 23, 2025 — 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 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT UNDERWENT THR ON (B)(6) 2015 LEFT HIP REVISED ON (B)(6) 2019 DUE MULTIPLE HIP DISLOCATION. THE FEMORAL STEM ORIGINALLY USED WAS A PROFEMUR Z CLASSIC SIZE 5 SHORT STRAIGHT NECK AND FEMORAL HEAD WAS A BIOLOX DELTA 28MM S, DOUBLE MOBILITY POLYETHYLENE LINER WAS USED. ONLY THE FEMORAL HEAD AND LINER WERE REVISED THERE IS NO FURTHER DATA ON WHAT DEVICES WERE IMPLANTED AFTER REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21219055 ↗
• InjuryDec 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, THE ARTIFICIAL HEAD WAS DISLOCATED, AND THE BIPOLAR CUP WAS DISLOCATED DURING MANUAL HEALING. AN EMERGENCY CONTEMPLATIVE SURGERY WAS PERFORMED AND THE CUP WAS REPLACED WITH A THA WITH DUAL MOBILITY. PHYSICIAN'S FINDINGS: THE DISLOCATION LED TO A SURGERY THAT WAS VERY BURDENSOME TO THE PATIENT. THE PATIENT WAS ASKED TO INVESTIGATE THE CAUSE AND REPORT BACK. FINDINGS OF THE REPORTER AND STATUS OF RESPONSE: THE RING OF THE BIPOLAR CUP IS FIXED, AND IT IS A PUZZLING CASE AS TO HOW THE PROLAPSE OCCURRED. ONLY CUP AND HEAD RETURN. RELATED MPO PRODUCTS: PRODUCT ID: PRTLS027 PROFEMUR® TL CLASSIC STEM SIZE 7 STRAIGHT SHORT NECK/ LOT NO.: 1802476/ QTY: 1. (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20907183 ↗
• InjuryJun 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, THE PATIENT HAS PAIN, AND HAS BEEN REVISED FROM THE COCR NECK TO THE TI NECK. PATIENT STATED HAD FRETTING, BUT HER COCR LEVELS WERE NOT TOO ELEVATED BASED ON WHAT THE DOCTOR TOLD. PRODUCTS NOT REVISED: DSPCGB48 PRODUCT ID: DYNASTY PC SHELL LOT# 1417042 QTY: 1. DLXPGB28 PRODUCT ID: DYNASTY POLY LINER LOT# 1567743 QTY: 1. PLS0R413 PRODUCT ID: PROFEMUR RENAISSANCE STEM LOT# 1550698 QTY: 1.

  Patient problems: Pain

  MAUDE report 17039330 ↗
• InjuryMar 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, QS DIRECTOR RECEIVED A CALL FROM A PATIENT, FOR SOME REASON PATIENT HAS BEEN EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 16637272 ↗
• InjuryOct 19, 2022Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. COMPONENT IS NOT MPO: AVANTAGE E1 INSERT Ø28 T.58 PRODUCT ID: P0561E58 LOT#: 770406 SRNJR NUMBER: (B)(4). SIDE:R. FRASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Unspecified Infection

  MAUDE report 15632835 ↗
• InjurySep 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION.

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

  MAUDE report 12407037 ↗
• InjuryJul 7, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO LOOSENING STEM. HEAD/SOCKET MISMATCH. ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS. (B)(4). SIDE:L; PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Metal Related Pathology

  MAUDE report 12132685 ↗
• InjuryMar 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT UNDERWENT THR ON (B)(6) 2021, DISLOCATED 5 WEEKS POST-OP. REVISED ON (B)(6) 2021 WITH A LINEAGE/TRANSCEND HEAD AND ANOTHER MANUFACTURER'S CUP AND LINER. CAUSE OF DISLOCATION IS EITHER CUP POSITIONING OR PATIENT'S KNOWN SPINAL ISSUES WITH A HISTORY OF SPINAL FUSION. (B)(6).

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

  MAUDE report 11472888 ↗
• InjuryNov 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION SUBLUXATION; MALALIGNMENT SOCKET; PERIPROSTHETIC FRACTURE STEM. REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P1 - FIT AND HEALTHY. MHRA REFERENCE NO: (B)(4).

  Patient problems: No Information

  MAUDE report 10913553 ↗
• InjuryMar 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION. MPO PROCOTYL IMPLANTS REMOVED AND REPLACED WITH MPO DYNASTY IMPLANTS. 28MM FEMORAL HEAD REMOVED AND CHANGED TO 32MM FEMORAL HEAD. THE SURGEON BELIEVES THAT AN ERROR IN RELOCATING THE HIP CAUSED THE CUP TO MOVE. (B)(6).

  Patient problems: No Information

  MAUDE report 9868205 ↗