BIOLOX DELTA CER LNR 36MM E
Report
- Report Number
- 3002806535-2025-00204
- Event Type
- Injury
- Date Received
- May 22, 2025
- Date of Event
- April 29, 2025
- Report Date
- April 23, 2026
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LZO
- UDI-DI
- 00887868271144
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10: ITEM NAME: G7 PPS LTD ACET SHELL 52E; ITEM NUMBER: 010000663; LOT NUMBER: 7772258. ITEM NAME: TPRLC 133 MP 12/14 BM HO 12.0; ITEM NUMBER: 51-137120; LOT NUMBER: 6493698. ITEM NAME: DELTA CER FM HD 036/-4MM 12/14; ITEM NUMBER: 650-0836; LOT NUMBER: 3223519. G2 ¿ FOREIGN ¿ POLAND. G4: 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H11. FOUR LARGER FRACTURED PIECES AND TWENTY-ONE FRAGMENTED PIECES WERE RETURNED. IT'S UNKNOWN IF ALL PIECES ARE RETURNED. METAL TRANSFER MARKS ARE PRESENT ON FRACTURED SURFACES, OUTER SPHERICAL SURFACES, POLAR BOSS, AND INNER SPHERICAL SURFACES. NO OTHER DAMAGE WAS NOTED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. A DEFINITIVE ROOT CAUSE COULD NOT 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1, A2, A3, A4, B4, B5, B7, D2A, D6, G2, G3, G6, H2, H6, H10, H11. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION SURGERY DUE TO A FRACTURED CERAMIC LINER, APPROXIMATELY 1 MONTH AND 23 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT TO HIP REVISION SURGERY DUE TO EXPERIENCED PAIN, SNAPPING SENSATION AND CREPITUS. CERAMIC LINER AND HEAD EXCHANGED, CERAMIC HEAD WAS FOUND TO HAVE FRACTURED. APPROXIMATELY 55 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 531808 | BIOLOX DELTA CER LNR 36MM E | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS | LZO | BIOMET UK LTD. | 3212481 | 00887868271144 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |