REVISION REVISION HIP - Ti6Al4V (REF 3816.15.010)Recalls & reported problems
Limacorporate SPA · Uncemented Stem Dia=20mm - L=140mm · 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 08033390003902), received between Jul 8, 2025 and Jul 8, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2025Break; Break
REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO BREAKAGE OF REVISION MOD. STEM. (PRODUCT CODE: 3816.15.010 - LOT: 1110071 - STER. (B)(4)). IT WAS REPORTED NO TRAUMA. FRACTURE OF STEM CONUS. THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2014 AFTER FRACTURE. THE FOLLOWING LIMACORPOARATE DEVICES WERE ALL EXPLANTED: · REVISION MOD. STEM Ø20MM (PRODUCT CODE: 3816.15.010, LOT: 1110071 - STER. (B)(4)) - SOLD IN US. · DELTA NEUTR.LINER ØINT 32MM #M (PRODUCT CODE: 5885.51.158, LOT: 1313238 - STER.(B)(4)). · REVISION LATER. NECK H.60MM (PRODUCT CODE: 7515.15.110, LOT: 1011926 - STER. (B)(4)). ALSO, A DEVICE MANUFACTURED BY DEPUY WAS EXPLANTED: BIOLOX DELTA CERAMIC FEMORA HEAD (DEPUY - CODE: 1365.32.320 - LOT: 7838723). PATIENT IS A MALE, 51 YEARS OLD, APPROXIMATE HEIGHT 184 CM, APPROXIMATE WEIGHT 100KG. EVENT OCCURRED IN SWITZERLAND.
Patient problems: Insufficient Information
MAUDE report 22435545 ↗
Other Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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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