FDA Adverse Event
Injury
Summary report: N
BIOLOX DELTA HEAD
MDR report key: 23789485
·
Received December 12, 2025
Report
- Report Number
- 3008021110-2025-00166
- Event Type
- Injury
- Date Received
- December 12, 2025
- Date of Event
- November 5, 2025
- Report Date
- December 11, 2025
- Manufacturer
- LIMACORPORATE S.P.A
- Product Code
- LZO
- UDI-DI
- 08033390007184
- PMA / PMN Number
- K141327
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
REVIEW OF MANUFACTURING RECORDS DID NOT IDENTIFY ANY PRE-EXISTING ANOMALY OR NONCONFORMITY THAT COULD HAVE CONTRIBUTED TO REPORTED ISSUE. THE MANUFACTURER WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 0
REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO HIP FRACTURE. ISSUE WAS REPORTED TO HAVE INVOLVED THE FEM. MODULAR HEAD - M Ø28MM (PART NUMBER: 5010.42.282, LOT: 1781396, STERILIZATION: 2200312) AND SURGEON IMPLANTED DELTA CUP MOBILE LINER DIA 42MM FOR HEADS DIA 28MM (PART NUMBER: 5566.50.420) DURING REVISION TO SOLVE THE ISSUE. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2024. PATIENT IS MALE, DATE OF BIRTH ON (B)(6) 1950. THE EVENT OCCURRED IN THE UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2769421 | BIOLOX DELTA HEAD | BIOLOX DELTA HEAD 28MM #M | LZO | LIMACORPORATE S.P.A | 5010.42.282 | 1781396 | 08033390007184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |