NA 1363-41-000Recalls & reported problems
Depuy Orthopaedics, Inc. · MODULAR CATHCART FRACTURE HEAD HIP BALL 41mm OD +5mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295032731), received between Feb 28, 2018 and Aug 13, 2025 — classified as 4 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Device Dislodged or Dislocated1
Patient problems
- Unspecified Infection3
- Joint Dislocation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 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 INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SIDE.
Patient problems: Unspecified Infection
MAUDE report 22797315 ↗InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT WASHOUT AND HEAD EXCHANGE WAS PERFORMED FOR INFECTION. DOI: UNKNOWN. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 21275667 ↗InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION COMPLETED DUE TO SUSPECTED INFECTION. IT IS UNKNOWN IF INFECTION WAS PRESENT. 41 UNIPOLAR HEAD AND CEMENTED IN AB CUP SPACERS WERE REMOVED . THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 15555316 ↗InjuryFeb 28, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
DER STATES THAT THE PATIENT DISLOCATED UNIPOLAR AT SKILLED NURSING FACILITY. CONVERTED TO BIPOLAR. DOI: (B)(6) 2018; DOR: (B)(6) 2018 LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 7302261 ↗
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, ClassifiedMODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 13634600
Other Prosthesis, hip, hemi-, femoral, metal ball devices
- NA 1363-10-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball117 reports
- NA 1363-08-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball66 reports
- NA 1363-12-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball44 reports
- NA 1363-46-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball39 reports
- NA 1363-47-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball34 reports
- NA 1363-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball31 reports
- NA 1363-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball25 reports
- NA 1363-49-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball23 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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