FDA Adverse Event
Injury
Summary report: N
BIOLOX DELTA OPTION HEAD, 28MM
MDR report key: 23579374
·
Received November 18, 2025
Report
- Report Number
- 3002806535-2025-00538
- Event Type
- Injury
- Date Received
- November 18, 2025
- Date of Event
- October 9, 2025
- Report Date
- April 24, 2026
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LZO
- UDI-DI
- 00887868271373
- PMA / PMN Number
- K192683
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4). D10: CAT# 110024461 LOT# 404810 G7 DUAL MOBILITY LINER 38MM C. CAT# 650-1064 LOT# 3123237 CER OPTION TYPE 1 TPR SLEVE -6. G2: FOREIGN - EVENT OCCURRED IN JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO THE HEAD AND BEARING DISASSOCIATION, CONSISTENT WITH INTRAPROSTHETIC DISLOCATION. THE HEAD AND BEARINGS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 442621 | BIOLOX DELTA OPTION HEAD, 28MM | PROSTHESIS, HIP | LZO | BIOMET UK LTD. | 3128049 | 00887868271373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R |