BIOLOX DELTA CER LNR 36MM E
Report
- Report Number
- 3002806535-2025-00534
- Event Type
- Injury
- Date Received
- November 13, 2025
- Date of Event
- October 20, 2025
- Report Date
- February 6, 2026
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LPH
- UDI-DI
- 00887868271144
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H11. THE FOLLOWING SECTION WAS CORRECTED: H6 - COMPONENT CODE THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. THE PRODUCT INVOLVED IN THE REPORTED EVENT WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, A PICTURE WAS PROVIDED AND SHOWS THE HEAD AND THE LINER EXPLANTED WITH BLOOD ON. THE HEAD EXHIBITS MARKING WHICH IS VISUALLY CONSISTENT WITH METAL TRANSFER. IT IS UNKNOWN IF THIS OCCURRED FROM THE DISLOCATIONS OR DURING EXPLANT. NO FURTHER EVALUATION CAN BE MADE. A SINGLE UNDATED RADIOGRAPH WAS RECEIVED AND ASSESSED AND NOT SUBMITTED TO RADIOLOGY AT THIS TIME. BECAUSE THERE IS NO DATE, IT IS UNKNOWN WHEN THIS MIGHT HAVE BEEN TAKEN AS THERE IS A 1-YEAR TIMEFRAME BETWEEN INITIAL SURGERY AND REVISION FOR DISLOCATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10: 650-0661, DELTA CERAMIC FEM HD, 36/0MM, LOT 3194574. G2: FOREIGN - EVENT OCCURRED IN NEW ZEALAND. G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K190660. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H10, H11. THE FOLLOWING SECTION WAS CORRECTED: H6 - DEVICE CODE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THE PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY ONE-YEAR POST-IMPLANTATION DUE TO HIP DISLOCATION AND INSTABILITY. A CONSTRAINED LINER WAS IMPLANTED TO ADDRESS THE INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84368 | BIOLOX DELTA CER LNR 36MM E | HIP PROTHESIS | LPH | BIOMET UK LTD. | 3137922 | 00887868271144 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Unknown | Hospitalization| R | SEE H11 NARRATIVE |