PROCOTYL PHA04410Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI M684PHA044101), received between Jun 25, 2019 and Feb 10, 2025 — classified as 11 injuries, 1 malfunction.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL STUDY # (B)(6). PATIENT #(B)(6) REPORTED THE FOLLOWING ADVERSE EVENT: HIP DISLOCATION. DISLOCATION WAS TREATED WITH CLOSE REDUCTION. THIS ADVERSE EVENT DID NOT END IN RE-REVISION SURGERY. NO FURTHER INFORMATION IS PROVIDED DUE TO PRIVACY POLICIES.

  Patient problems: Insufficient Information

  MAUDE report 21343275 ↗
• InjuryDec 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT THR ON (B)(6) 2019. REVISED ON (B)(6) 2024 DUE TO AN INFECTION. WASHOUT PERFORMED, HEAD AND LINER REPLACED. AUSTRALIA-C24-597.

  Patient problems: Unspecified Infection

  MAUDE report 21023264 ↗
• InjuryNov 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, RECENT HIP REVISION DUE TO INFECTION. PRODUCTS IMPLANTED DURING REVISION SURGERY: PRODUCT: PHA06264 ACETABULAR CUP "PROCOTYL® L", LOT: 1979369, QTY: 1 PRODUCT: PHA04660 RIM-LOCK "A-CLASS®" ACETABULAR, LOT: 1949753 QTY: 1 PRODUCT: PHA04412 FEMORAL HEAD BIOLOX DELTA, LOT: 1884368 QTY: 1 AUSTRALIA-C24-515.

  Patient problems: Unspecified Infection

  MAUDE report 20682949 ↗
• InjuryAug 10, 2022Corroded; Unstable; Device Dislodged or Dislocated; Corroded; Unstable; Device Dislodged or Dislocated

  ALLEGEDLY, ON OR ABOUT APRIL 30, 2014 PATIENT HAD A PROFEMUR TOTAL HIP SYSTEM IMPLANTED IN HER RIGHT HIP. ON OR ABOUT (B)(6) 2019 PATIENT REPORTED FOR REVISION SURGERY DUE TO ELEVATED COBALT AND CHROMIUM LEVELS, PAIN AND EVIDENCE OF A PSEUDOTUMOR. PATIENT'S FIRST REVISION WAS NECESSARY BECAUSE THE DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION. IT WAS DISCOVERED CORROSION OF THE PROFEMUR COCR MODULAR NECK WHERE IT SEATED IN THE POCKET OF THE MODULAR STEM. THE IMPLANTED NECK AND HEAD WERE REVISED. AFTER THE REVISION SURGERY PATIENT REPORTED AT LEAST 3 DISLOCATIONS. THE PREVIOUS EVENTS WERE CAPTURED UNDER MICROPORT ORTHOPEDICS GROUP NUMBER: (B)(4). ADDITIONAL INFORMATION RECEIVED 7/21/2022: ALLEGEDLY, ON OR ABOUT (B)(6) 2021, PATIENT REPORTED FOR A REVISION SURGERY OF THE RIGHT TOTAL HIP ARTHROPLASTY, REVISION OF BOTH THE ACETABULAR AND FEMORAL COMPONENTS. SURGEON RECOMMENDED THIS SECOND REVISION SURGERY DUE TO RECURRENT INSTABILITY WITH DISLOCATIONS. DURING REVISION SURGERY, SURGEON DETERMINED THE ONLY WAY TO SAFELY REMOVE THE MODULAR STEM WAS TO PERFORM AN EXTENDED TROCHANTERIC OSTEOTOMY(ETO), WHICH REQUIRED FOUR DALL MILES CABLES WITH THE USE OF A 240 MM REVISION STEM. S

  Patient problems: Metal Related Pathology; Osteopenia/ Osteoporosis

  MAUDE report 15199620 ↗
• InjuryMay 30, 2022Crack; Device Dislodged or Dislocated; Crack; Device Dislodged or Dislocated

  ALLEGEDLY, THE CT REPORT ON (B)(6) 2021 SHOWS A DISLOCATION OF THE ACETABULAR PART OF THE HIP ENDOPROSTHESIS, OSTEOLYSIS AND PAIN. THE SAME RESULT ALSO SHOWS THAT OLDER RADIOGRAPHS SHOW A SIGNIFICANT REACTION IN THE AREA OF THE LEFT HIP WITH LAYERS ALONG THE LEFT HIP PROSTHESIS. PX PERFORMED AN X-RAY ON (B)(6) 2021 AND THE RESULTS SHOW THAT THERE WAS THINNING OF THE BONE IN THE ACETABULAR PART OF THE ENDOPROSTHESIS AND IN THE FEMUR. LOSS OF MOBILITY DUE TO PAIN. PRODUCTS NOT REVISED, ALLEGEDLY REVISION SURGERY SCHEDULED FOR (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 14543610 ↗
• InjurySep 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION. COMPONENTS NOT REVISED: PRODUCT NAME: PROFEMUR® R PROX BODY PLASMA SPRAY X-SMALL MODULAR PRODUCT ID: PPW38354. PRODUCT NAME: PROFEMUR® ROUGHENED DISTAL STEM, TAPERED PRODUCT ID: PPW38022. PRODUCT NAME: PROFEMUR® MODULAR FEMORAL NECK PRODUCT ID: PHA01224.

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

  MAUDE report 12421621 ↗
• InjuryJul 28, 2021Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 12241897 ↗
• InjuryApr 13, 2020Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  ALLEGEDLY, LEFT HIP ENDOPROSTHESIS DISLOCATION DUE TO EXTENSIVE INTERNAL ROTATION OF THE HIP JOINT, CLOSED REDUCTION AND IMMOBILISATION RESOLVED THE PROBLEM, NO FURTHER INSTABILITY OF THE ENROLLED HIP.

  Patient problems: No Information

  MAUDE report 9954046 ↗
• MalfunctionSep 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN. REVISION (B)(4). SIDE:L: PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED: PROCOTYL L BEADED AND HA COATED CUP SIZE 54MM (B)(4). RIM-LOCK A-CLASS CROSS-LINKED POLYETHYLENE LINERS 0 DEG 32MM ID GROUP E (B)(4).

  Patient problems: Pain

  MAUDE report 8996407 ↗
• InjuryJul 17, 2019Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  ALLEGEDLY PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. TWO WEEKS AFTER THE OPERATION, THE PATIENT POINTED OUT THAT "THE RATTLE NOISE OCCURS IN THE BODY", AND THE SOUND DISAPPEARED A FEW DAYS LATER, BUT WHEN CT WAS TAKEN, THE 32 MM HEAD WAS ACETABULAR. BECAUSE IT WAS AT A POSITION OFFSET FROM THE LID CUP, IT IS PRESUMED THAT THE POLYETHYLENE LINER WAS LIKELY TO BE DISLOCATED, AND DAY 21 POLY LINER REMOVAL + REPLACEMENT SURGERY WAS PERFORMED.

  Patient problems: Missing Value Reason

  MAUDE report 8798022 ↗
• InjuryJun 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAIN. THE MICROPORT SHELL AND LINER IMPLANTED WITHIN THE PRIMARY SURGERY WERE NOT REVISED. SRNJR NUMBER: (B)(4), SIDE: R, FRASA: P2-MILD DISEASE NOT INCAPACITATING.

  Patient problems: Pain

  MAUDE report 8732935 ↗
• InjuryJun 25, 2019Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING SOCKET; PAIN. MICROPORT HEAD, NECK AND STEM WERE IMPLANTED WITH A COMPETITOR'S SHELL AND LINER. SRNJR NUMBER: (B)(4), SIDE: L, FRASA: P3 INCAPACITATING SYSTEMATIC DISEASE. THE FOLLOWING COMPONENT HAVE NO ALLEGED DEFICIENCY AND WERE NOT REVISED DURING THIS SURGERY: PROFEMUR® L HIP STEM SIZE 2 HA COATED, PHA05504, LOT # 1526066, QTY. 1.

  Patient problems: Pain

  MAUDE report 8732933 ↗