CoCrMo Femoral Head (REF 5010.09.281)Recalls & reported problems
Limacorporate SPA · Modular femoral heads (CoCrMo) Dia. 28mm S 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 08033390006781), received between Nov 17, 2023 and Nov 17, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Problem” (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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2023Mechanical Problem; Mechanical Problem
HIP PROTHESIS REVISION SURGERY PERFORMED ON (B)(6), 2023. THE FEMORAL MODULAR HEAD - S Ø28MM (PRODUCT CODE 5010.09.281, LOT NR. 1505799) WAS NOT ABLE TO ROTATE INSIDE THE MOBILE LINER ØINT 28 MM Ø42 MM (PRODUCT CODE 5566.50.420, LOT NR. 15AT0LL - STER. 1500213). THIS CAUSED RECIDIEVE BRUISING AND A DECREASE OF RANGE OF MOTION. PATIENT IS A FEMALE, AGE 67. THE FOLLOWING COMPONENTS GOT EXPLANTED: - FEMORAL MODULAR HEAD - S Ø28MM (PRODUCT CODE 5010.09.281, LOT #1505799). - DELTA-ONE-TT ACETAB.CUP Ø56MM (PRODUCT CODE 5549.14.560, LOT #1505095 - STER. 1500151) - PRODUCT NOT SOLD IN THE US. - MOBILE LINER ØINT 28 MM Ø42 MM (PRODUCT CODE 5566.50.420, LOT #15AT0LL - STER. 1500213).
Patient problems: Implant Pain
MAUDE report 18158040 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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