NA 1363-10-000Recalls & reported problems
Depuy Orthopaedics, Inc. · MODULAR CATHCART TAPERED SPACER 12/14 TAPER +0mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Cathcart modular hip component, a metal part used in hip replacement surgery, has 116 adverse event reports on file. Many describe infection, pain, dislocation or fracture, and several describe revision surgery, sometimes converting a partial hip replacement to a total one. The reports include no deaths and 116 injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 117
- Deaths reported
- 0
- Injuries reported
- 117
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 10603295032670), received between Jul 21, 2017 and Jul 27, 2026 — classified as 117 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (18 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem96
- Insufficient Device Problem Information18
- Appropriate Device Problem Term/Code Not Available2
- Device Dislodged or Dislocated1
- Naturally Worn1
- No Apparent Adverse Event1
Patient problems
- Unspecified Infection73
- Pain37
- No Code Available29
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Insufficient Information3
- Not Applicable3
- Discomfort2
- Joint Dislocation2
Recent adverse event reports
The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.
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 50035759 ↗InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY TO HAVE THE HEMI ARTHROPLASTY CONVERTED TO TOTAL HIP DUE TO DEGENERATIVE ACETABULAR CHANGES AND ONSET OF PAIN. THE STEM WAS LEFT IN PLACE AND THE LEFT ACETABULAR IMPLANT WAS PLACED. NO ISSUES OR CONCERNS REPORTED WITH THE IMPLANTS. AFFECTED SIDE-LEFT.
Patient problems: Pain
MAUDE report 25633560 ↗InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
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: Insufficient Information
MAUDE report 25334129 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION. DOI-(B)(6) 2026. DOR-(B)(6) 2026. AFFECTED SIDE-RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 24758636 ↗InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT SHOWED SIGNS OF INFECTION WITH A DRAINING WOUND. AFFECTED SIDE: LEFT HIP.
Patient problems: Fluid Discharge; Unspecified Infection
MAUDE report 24582104 ↗InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DISLOCATED AFTER SURGERY. DOCTOR WANTED TO REVISE AND DECIDED TO CEMENT A STEM AND REPLACE COMPONENTS. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 24202756 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED THE PAINFUL HEMIARTHROPLASTY. IT WAS CONVERTED TO TOTAL HIP. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE- LEFT HIP.
Patient problems: Pain
MAUDE report 24073736 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS INFECTED, ALL IMPLANTS WERE EXTRACTED AND A PROSTALAC SPACER WAS IMPLANTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 23997387 ↗InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INFECTION. THE STEM SEPARATED FROM THE CEMENT MANTLE WHEN DISSOCIATING THE TAPER. NO HARM TO THE PATIENT WAS REPORTED. THE PROCEDURE WAS DELAYED FOR ABOUT THIRTY (30) MINUTES WHILE THE NEW CEMENT HARDENED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23716808 ↗InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT I&D FOR CONFIRMED INFECTION WITH HEAD EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 23556052 ↗InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 23544820 ↗InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE HIP WAS INFECTED. DOCTOR PERFORMED AN I&D AND SWAPPED THE HEAD AND TAPER ADAPTER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 23544477 ↗InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 23544313 ↗InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO IRRIGATION AND DEBRIDEMENT WITH HEAD EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 23536306 ↗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 23512930 ↗InjuryOct 30, 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) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 23430308 ↗InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 23423524 ↗InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT SUFFERED FROM INFECTION. AFFECTED SIDE- RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 23378362 ↗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 22797394 ↗InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD A SPACER PLACED. HIP WAS GROSSLY INFECTED. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22201748 ↗InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE HIP HEMIARTHROPLASTY WAS REVISED DUE TO PAIN. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 22148291 ↗InjuryApr 1, 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. IRRIGATION AND DEBRIDEMENT NEEDED WITH A HEAD/SPACER SWAP. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP SIDE.
Patient problems: Unspecified Infection
MAUDE report 21739973 ↗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 21617933 ↗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 21275674 ↗InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IRRIGATION AND DEBRIDEMENT WITH HEAD EXCHANGE. NO PATIENT CONSEQUENCE, NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 21211289 ↗
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 1363-08-000Depuy 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
- NA 1363-48-000Depuy 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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