NA 1363-46-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295032786), received between Oct 2, 2017 and Aug 6, 2026 — classified as 38 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K903084); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Degraded; Naturally Worn

  Patient problems: Pain

  MAUDE report 50156424 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to infection. DOI: (b)(6) 2026.DOR: (b)(6)2026.Affected side: Right hip.

  Patient problems: Unspecified Infection

  MAUDE report 50035760 ↗
• InjuryMay 29, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND FRACTURE OF HEMI. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25334259 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SIGNS OF INFECTION; I/D WAS PERFORMED AND HEAD/SLEEVE WERE REPLACED. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24333795 ↗
• InjuryOct 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED. IT WAS STATED THAT VISUAL INSPECTION OF THE RETURNED DEVICES REVEALED THE METAL HEAD (MODULAR CATHCART BALL 46MM OD, (B)(4). ASSEMBLED WITH THE HEAD ADAPTOR (B)(4).

  Patient problems: Bone Notching; Foreign Body Reaction; Joint Dislocation

  MAUDE report 23427309 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT HIP HEMIARTHROPLASTY ON (B)(6) 2025. THE PATIENT WAS VERY UNSTABLE AND CAME IN FOR A SECOND OPINION. THE SURGEON DECIDED THAT IT WOULD BE BENEFICIAL FOR THE PATIENT TO DO A CONVERSION TO A TOTAL HIP REPLACEMENT ON THE ACETABULAR SIDE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22688393 ↗
• MalfunctionApr 1, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT REVISED FROM HEMI TO TOTAL. NO IMPLANT FAILURE. NO BROKEN PIECES. NO CASE DELAY. NO LOOSENING. THERE WAS NO PATIENT HARM. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 21740277 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED ARTHRITIS IN HER ACETABULUM. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Arthritis

  MAUDE report 20257881 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED ON (B)(6) 2024 INCLUDING IRRIGATION AND DEBRIDEMENT DUE TO INFECTION WITH HEAD EXCHANGE. PATIENT WAS ORIGINALLY IMPLANTED ON THE LEFT HIP, ON (B)(6) 2024. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20250044 ↗
• InjuryApr 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ACETABULAR WEAR AND PAIN. DOI: (B)(6) 2017 DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 19105612 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION AND REPLACED WITH A BALL OF CEMENT, THEN REIMPLEMENTED ON (B)(6) 2024. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18720899 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A HEMI AND WAS PAINFUL POST OP SO WE CONVERTED TO THA WITH DUAL MOBILITY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6), 2024. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18699160 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND BOARDED FOR A HIP IRRIGATION AND DEBRIDEMENT (I&D) WITH HEAD SWAP. WHILE DISLOCATING THE FEMUR THE DOCTOR NOTICED THE STEM MOVING. THE STEM WAS LOOSE. CEMENT MANTEL WAS REMOVED AND A NEW HEMI WAS PUT IN AFTER A WASH OUT WAS PERFORMED. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT HIP

  Patient problems: Unspecified Infection

  MAUDE report 18277205 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN INFECTION IN THE AREA. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2023. DOR- UNKNOWN. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17556035 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO FAILED HEMIARTHROPLASTY. PATIENT HAD EVIDENCE OF METALLOSIS IN THE ACETABULUM AND PSEUDOTUMOR IN CAPSULAR STRUCTURES AND GLUTEUS. REVISED TO PINNACLE 52 CUP 36 ID POLYETHYLENE LINER AND 36+6 CERAMIC TS HEAD. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 16059877 ↗
• InjuryJun 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REMOVAL OF IMPLANTS DUE TO EROSION OF ACETABULUM/ DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: MAY 25,2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Pocket Erosion

  MAUDE report 14653792 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. NEW HEAD AND SPACER IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14594676 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ACETABULAR PAIN. DOI: (B)(6) 2021, DOE: (B)(6) 2021, LEFT HIP.

  Patient problems: Pain

  MAUDE report 13192246 ↗
• InjuryJul 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD HIP REVISION FROM HEMI TO TOTAL WITH A CONSTRAINED LINER DUE TO MULTIPLE DISLOCATIONS AFTER A FALL. DOI: (B)(6) 2014, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation; No Code Available

  MAUDE report 10308560 ↗
• InjuryJul 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A VERY ELDERLY LADY WITH DEMENTIA WHO BECAME A CHRONIC DISLOCATER. THE SURGEON TOOK ALL IMPLANTS OUT AND LEFT A GIRDLESTONE. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10308006 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS INFECTION. DID A WASHOUT AND HEAD SWAP. DOI: (B)(6) 2020; DOR: (B)(6) 2020; AFFECTED SIDE: UNKNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10251327 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2019, DOR: (B)(6). 2020, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10130416 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION WAS DUE TO PAINFUL RIGHT HIP AND WAS CONVERTED HEMI TO TOTAL HIP. THERE IS NO ADDITIONAL INFORMATION. DOI: (B)(6) 2018. DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10108633 ↗
• InjuryMay 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD CHRONIC DISLOCATION. DOI: (B)(6) 2020, DOR: (B)(6), 2020; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10025605 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HIP BECAME INFECTED. SURGEON DID A SIMPLE WASH OUT AND REPLACED THE UNIPOLAR HEAD AND CATHCART. THE PRODUCTS WERE NOT DEFECTIVE BUT THE SURGEON REMOVED AS MUCH INFECTED TISSUE AND HARDWARE AS POSSIBLE. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9891538 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K903084. One submission often covers many models, so check the product and lot details in each record.

• Z-1375-2022 · May 18, 2022 · Open, Classified
  MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 13634600