NA 1363-52-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295032847), received between Aug 31, 2017 and Nov 10, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS ACETABULAR WEAR, SO THE DOCTOR CONVERTED THEIR ENDO PROSTHESIS INTO A TOTAL HIP. NO DELAYS OR PATIENT INJURY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Notching; Insufficient Information

  MAUDE report 23512929 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ARTHRITIC SOCKET. UNKNOWN SURGICAL DELAY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 22020373 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO HIP BECAME INFECTED. THERE WAS IRRIGATION AND DEBRIDEMENT. THE SURGEON PULLED OUT OLD HEAD/SPACER AND PUT IN A NEW ONE. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21617932 ↗
• InjuryApr 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO THE DISLOCATION DUE TO SPINAL FUSION. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14142637 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POST SURGERY INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14041500 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID AN IMPLANT EXCHANGE DUE TO INFECTION. THE SURGEON IMPLANTED A PROSTALAC IMPLANT. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13731886 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HER ORIGINAL ANTIBIOTIC SPACER PLACED ON (B)(6) 2021 THEN HAD IT WASHED OUT AGAIN ON (B)(6) 2021 AND IT WAS CONVERTED TO A HEMI AT THAT TIME. SHE HAD AN ASPIRATION ON THIS PAST THURSDAY BECAUSE HER HIP WAS PAINFUL AGAIN AND SHE IS NOW GROWING A DIFFERENT THEN SHE WAS BEFORE. THE DOCTOR HAS DECIDED TO REMOVE EVERYTHING IN THE HIP, WASH IT OUT AGAIN AND REDO THE ANTIBIOTIC SPACER. DOI: (B)(6) 2021 ; DOR: (B)(6) 2021 ; LEFT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13010709 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS HIP BECAME INFECTED. WE DID AN I&D AND HEAD REMOVAL. IMPLANTS WERE IN ONE PIECE AND NOT DEFECTIVE. DOI: (B)(6) 2021. DOR: (B)(6) 2021. HIP UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12861339 ↗
• InjuryJul 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. DOI: (B)(6) 2021. DOR: (B)(6) 2021; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12219590 ↗
• InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS' HIP WAS INFECTED. THE HIP HEMI CONSTRUCT WAS REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. DOI: (B)(6) 2020, DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10019018 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I AND D WITH HEAD EXCHANGE FOR CONFIRMED INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9557433 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT HIP REVISION - PATIENT COMPLAINED OF HIP PAIN. ORIGINAL DATE OF SURGERY (B)(6) 2018. CONVERTED HEMI HIP TO TOTAL HIP - REMOVED STEM, CATHCART AND SLEEVE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES. WERE FRAGMENTS GENERATED? --> UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN. (B)(4). DEVICE PROPERTY OF -->NONE. DEVICE IN POSSESSION OF -->NONE. (B)(4). DEVICE PROPERTY OF -->NONE. DEVICE IN POSSESSION OF -->NONE. (B)(4). DEVICE PROPERTY OF -->NONE. DEVICE IN POSSESSION OF -->NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Code Available; Pain

  MAUDE report 9261938 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT HIP REVISION - CONVERTING HEMIARTHROPLASTY TO TOTAL HIP. ORIGINAL SURGERY DONE (B)(6) 2013. THE REASON FOR REVISION WAS THE PATIENT COMPLAINED OF ACETABULAR PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8623305 ↗
• InjuryJun 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS ALSO INDICATED THAT THE SURGEON REMOVED THE UNIPOLAR HEAD AND SLEEVE, REPLACED WITH A COMPETITOR DUAL MOBILITY AND DEPUY FEMORAL HEAD. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7650427 ↗
• InjuryMay 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION, CUP AND STEM LOOSENING. IT WAS ALSO INDICATED IN STICKERS SHEETS THAT TAPERED SPACER ARTICULEZE, MODULAR CATHCART BALL AND SUMMIT POR TAPER WERE IMPLANTED ON (B)(6) 2011. DOI: (B)(6) 2011; DOR: (B)(6) 2012; LEFT HIP. (B)(4) - 1ST REVISION ;(B)(4) -2ND REVISION; (B)(4) -3RD REVISION.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7514264 ↗
• InjuryApr 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7471934 ↗
• InjuryJan 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. (B)(6) 2017; (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7214797 ↗
• InjuryJan 12, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017. DOR: (B)(6) 2017. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7185576 ↗
• InjuryAug 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6835793 ↗

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