CoCr Femoral Ball Head 01.25.032Recalls & reported problems
Medacta International SA · Femoral Head Ø 36 size L · Class 2 · Implant
All models of CoCr Femoral Ball Head (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030805226), received between Nov 5, 2019 and Jul 25, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).
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
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Device Appears to Trigger Rejection1
- Device Dislodged or Dislocated1
Patient problems
- Inflammation1
- Joint Disorder1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
REVISION DUE TO INFLAMMATION FOR SUSPECTED TRUNNIONOSIS, ABOUT 6 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY. CUP, LINER, AND HEAD REVISED.
Patient problems: Inflammation
MAUDE report 17387413 ↗InjuryNov 5, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PERFORMED 1 DAY AFTER THE PRIMARY DUE TO DISLOCATION (HEAD FROM THE LINER). THE SURGEON REVISED THE STEM MASTERLOC LATERALIZED #10 WITH A MASTERLOC LATERALIZED #12, THE 36MM COCR HEAD L WITH A 40MM BIOLOX DELTA HEAD L, AND THE MPACT FLAT LINER HC 36/G WITH A MPACT FLAT LINER HC 40/G. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON USES ORTHOVIEW TEMPLATING. THE FEMORAL HEAD AND NECK WERE ANTERIORLY ROTATED AND THE PATIENT THE DISLOCATED ANTERIORLY.
Patient problems: Joint Disorder
MAUDE report 9278374 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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