REVISION REVISION HIP - Ti6Al4V (REF 3816.15.020)Recalls & reported problems
Limacorporate SPA · Uncemented Stem Dia=20mm - L=200mm · Class 2 · Implant
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 08033390003919), received between May 20, 2025 and Dec 19, 2025 — classified as 2 injuries.
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
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE SCREW BETWEEN THE REVISION MOD. STEM Ø20 MM (PRODUCT CODE: 3816.15.020, LOT: 1500622 - STER: (B)(4)) AND THE NECK (PRODUCT CODE: 7515.15.105) BECAME LOOSE POST-OPERATIVELY. REVISION SURGERY PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINT SOURCE, IT IS POSSIBLE THAT A SMALL PIECE OF STERILE PLASTIC WRAPPING FROM THE STEM BECAME LODGED BETWEEN THE STEM AND THE NECK; HOWEVER, THIS CANNOT BE CONFIRMED THE PATIENT UNDERWENT THE PRIMARY SURGERY IN 2016, FOLLOWED BY A FIRST REVISION ON (B)(6) 2018. THE SECOND REVISION SURGERY WAS THEN PERFORMED ON (B)(6) 2025, WHICH IS THE PROCEDURE RELATED TO THE CURRENT COMPLAINT. PATIENT: MALE, 100KG, 185CM. EVENT OCCURRED IN SWITZERLAND.
Patient problems: Insufficient Information
MAUDE report 23849590 ↗InjuryMay 20, 2025Break; Break
REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO BREAKAGE OF THE REVISION HIP - UNCEMENTED STEM D.20 MM L.200 MM (PRODUCT CODE: 3816.15.020 - LOT: 1308341). TOGETHER WITH THE STEM THE REVISION NECK (7515.15.010) WAS ALSO EXPLAINED (LOT NUMBER UNKNOWN).THE EVENT OCCURRED IN SWITZERLAND.
Patient problems: Insufficient Information
MAUDE report 22051068 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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