NA 1014-71-000Recalls & reported problems
Depuy (Ireland) · TOTAL HIP BALL FEMORAL HEAD Diameter 32mm +15 14/16 TAPER · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295001287), received between Dec 21, 2017 and Apr 1, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Joint Dislocation1
- Joint Laxity1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 21746361 ↗InjuryJul 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PRIOR TO SURGERY, THEY CEMENTED IN A COMPETITOR LINER INTO A COMPETITOR CAGE AND JUST REPLACED THE HEAD WITH OUR 14/16 LARGE TAPER HEAD. THIS TIME IT DISLOCATED AGAIN, SO THEY CEMENTED IN A COMPETITOR CONSTRAINED LINER AND WE PUT ANOTHER ONE OF OUR HEADS IN. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 7726082 ↗InjuryDec 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION DUE TO THIGH PAIN. ALL COMPONENTS ARE WELL FIXED, ONLY HEAD EXCHANGED. DOI: (B)(6)2016; DOR: (B)(6) 2017; LEFT HIP.
Patient problems: Pain
MAUDE report 7137636 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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