NA 1363-56-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295032878), received between Apr 27, 2018 and Nov 9, 2023 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN INFECTION SO SURGEON SWAPPED THE UNIPOLAR AND SPACER AND WASHED THE PATIENT OUT. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18101684 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR A WASHOUT AND PLACEMENT OF ANTIBIOTIC BEADS TO CURE AN INFECTION. THE SURGEON DECIDED IT BEST TO SWAP THE HEAD AND SPACER. UNKNOWN SURGICAL DELAY. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16662764 ↗
• InjuryFeb 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HIP WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16378849 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE THE FRACTURE HEAD HIP BALL WAS TOO BIG AND NOT SITTING ALL THE WAY DOWN INTO THE ACETABULUM. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 15723748 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP AFFECTED.

  Patient problems: Pain

  MAUDE report 14041448 ↗
• MalfunctionMay 17, 2021Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT AT SURGERY FOR A HEMI ARTHROPLASTY OF THE LEFT HIP IN AN ELDERLY PATIENT, THE TRIAL WAS PERFORMED WITH A GOOD REDUCTION AND GOOD LIMB LENGTH ALIGNMENT USING A 56 HEAD TRIAL. THE STEM WAS CEMENTED AND A FURTHER TRIAL PERFORMED WITH A 56 HEAD TRAIL- STANDARD NECK. THIS FITTED WELL WITH A GOOD REDUCTION AND GOOD LIMB LENGTH ALIGNMENT USING A 56 HEAD TRIAL. THE REAL METAL 56 HEAD WAS THEN PLACED ON THE NECK BUT WOULD NOT PROGRESS TO BE FULLY SEATED. EXAMINATION THEN REVEALED THAT THE HEAD WAS ABUTTING ON SOME PROMINENT BONY PROCESS OF THE GREATER TROCHANTER. THE METAL HEAD WAS REMOVED AND THE TRIAL TRIED AGAIN, AND AS IT WAS OF A DIFFERENT CONFIGURATION (HALF A HEMISPHERE) TO THE REAL HEAD 3/4HEMISOHERE) THE TRIAL FITTED WELL WITH NO ABUTMENT. AT THIS POINT, A PLUS FIVE TRUNNION WAS USED AND THE TRIAL PLACED AND THE HIP REDUCED, WITH MILD LENGTHENING, BUT STABLE AND WITH A GOOD RANGE OF MOVEMENTS. THE REAL 56 METAL HEAD WAS THE PLACED ON THE PLUS 5 TRUNNION AND THIS SEATED WELL WITH NO ABUTMENT. THE HIP WAS THEN REDUCED AND CLOSED. THE PATIENT HAS MADE A GOOD POST-OP RECOVERY. IT WAS THEN APPARENT THAT THE TRIAL AND THE REAL HEAD DID NOT C

  Patient problems: Insufficient Information

  MAUDE report 11837718 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR BONE CEMENT WAS USED. IT WAS CONVERTED FROM A HEMI TO A TOTAL HIP REPLACEMENT. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10803656 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND DISCOMFORT. DOI: (B)(6) 2012. DOR: (B)(6) 2020. RIGHT HIP.

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 10097035 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HEAD EXCHANGE AND I&D DUE TO INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9616202 ↗
• InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO CONVERT A HEMI-HIP TO A TOTAL HIP DUE TO PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8274069 ↗
• InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Not Applicable; Pain

  MAUDE report 7467793 ↗

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