Femoral Head 5010.42.321Recalls & reported problems
Limacorporate SPA · Femoral Head - Dia.32mm Short Taper 12/14 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390298100), received between Dec 2, 2025 and Dec 2, 2025 — classified as 1 injury.
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 Problem1
Patient problems
- Medical device site infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT SOURCE REPORTED REVISION DUE TO INFECTION PERFORMED ON (B)(6) 2025. PREVIOUS SURGERY PERFORMED ON (B)(6) 2015. PATIENT 49 YEARS OLD. THE DEVICES EXPLANTED ARE THE FOLLOWING: · DELTA PROTR.LINER ØINT 32MM #M (PRODUCT CODE: 588651158, LOT: 1509428 - STER: (B)(4) - SOLD IN US. · BONE SCREW Ø6,5 H.25MM (PRODUCT CODE: 8420.15.020, LOT: 1507404 - STER: (B)(4)) - SOLD IN US. · SAM-FIT RIGHT MOD.FEM. STEM #1 (PRODUCT CODE: 4216.25.110, LOT: 1103050 - STER: (B)(4)) - NOT SOLD IN US. · MODULAR NECK STD-S (S1) (PRODUCT CODE: 4220.09.110, LOT: 1512295 - STER: (B)(4)) - NOT SOLD IN US. · FEM. MODULAR HEAD - S Ø32MM (PRODUCT CODE: 5010.42.321, LOT: 1482052 - STER: (B)(4)) - SOLD IN US. · DELTA-PF ACETAB.CUP Ø50 MM (PRODUCT CODE: 5551.25.500, LOT: 1500348 - STER: (B)(4)) - NOT SOLD IN US. · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE: 8420.15.010, LOT: 1507399 - STER: (B)(4)) - SOLD IN US.
Patient problems: Medical device site infection
MAUDE report 23692504 ↗
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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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