CoCrMo Femoral Head (REF 5010.09.283)Recalls & reported problems
Limacorporate SPA · Modular femoral heads (CoCrMo) Dia. 28mm L Taper 12/14 · Class 2 · Implant
Data updated Oct 16, 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 08033390006804), received between Apr 27, 2026 and Apr 27, 2026 — 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 16, 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.
InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAD PROSTHESIS INFECTION THAT REQUIRED REVISION OF THE IMPLANT. THE FOLLOWING COMPONENTS WERE EXPLANTED: LOCK BIPOL.SELF-CENT.HEAD Ø51 CODE 552709510, LOT 2106980 STER. (B)(4), FEM. MODULAR HEAD - L Ø28MM CODE 501009283, LOT 2303790 STER. (B)(4), H-MAX C STANDARD FEM. STEM #10 CODE 426007100, LOT 2226621STER. (B)(4). DURING THE REVISION A SPACER WAS IMPLANTED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2023, THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2023. PATIENT IS MALE, 69 YEARS OLD. EVENT OCCURRED IN SLOVENIA.
Patient problems: Medical device site infection
MAUDE report 24995511 ↗
Other Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 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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