BIOLOX DELTA CER LNR 36MM E
Report
- Report Number
- 3002806535-2025-00130
- Event Type
- Malfunction
- Date Received
- March 28, 2025
- Date of Event
- January 19, 2025
- Report Date
- September 15, 2025
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LZO
- UDI-DI
- 00887868271144
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- 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 00889024519848. D10: UNKNOWN HEAD; ITEM# UNKNOWN; LOT# UNKNOWN. UNKNOWN CUP; ITEM# UNKNOWN; LOT# UNKNOWN. G2 ¿ FOREIGN ¿ CHINA. 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 INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. 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. D10: ITEM NAME: TPRLC 133 T1 PPS SO 13X146MMTP; ITEM NUMBER: 51-103130; LOT NUMBER: 7371741. ITEM NAME: G7 PPS LTD ACET SHELL 52E; ITEM NUMBER: 010000663; LOT NUMBER: 7675231. ITEM NAME: G7 LONGEVITY HIGH WALL 36MM E; ITEM NUMBER: 20123605; LOT NUMBER: 66509182. ITEM NAME: DELTA CERAMIC FEM HD 36/-3MM; ITEM NUMBER: 650-0660; LOT NUMBER: 3140435. ITEM NAME: TRILOGY BONE SCR 6.5X20; ITEM NUMBER: 00-6250-065-20; LOT NUMBER: 65743157. ITEM NAME: TRILOGY BONE SCR 6.5X30; ITEM NUMBER: 00-6250-065-30; LOT NUMBER: 65550679. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. 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. A VISUAL REVIEW OF THE RETURNED CERAMIC LINER REVEALED DARK MARKS ON THE RIM, AS WELL AS ON THE INNER AND OUTER SPHERICAL SURFACES. THE DARK MARKS ON THE TAPER REGION OF THE LINER SHOW A PATTERN CONSISTENT WITH PRIMARY TRANSFER FROM THE SHELL. THIS TRANSFER IS NOT CIRCUMFERENTIAL, WHICH MAY INDICATE MISALIGNMENT DURING IMPACTION. NO OTHER DAMAGE WAS OBSERVED. REFERENCE DIMENSIONS FOR OVERALL HEIGHT AND DIAMETER WERE MEASURED TO CONFIRM SIZE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. THE VISUAL EVALUATION INDICATES A POSSIBLE MISALIGNMENT BETWEEN THE LINER AND THE CUP. IF AND TO WHAT EXTEND THIS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT REMAINS UNKNOWN. THEREFORE, 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.
IT WAS REPORTED THAT THE DURING INITIAL HIP SURGERY, THE HEAD WOULD NOT ASSEMBLE WITH THE CERAMIC LINER. THE SURGEON COMPLETED THE SURGERY USING A E1 POLY LINER. A 30 MINUTE DELAY WAS REPORTED, WAITING FOR THE NEW POLY LINER. NO HARM TO THE PATIENT. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1470184 | BIOLOX DELTA CER LNR 36MM E | HIP PROSTHESIS | LZO | BIOMET UK LTD. | 3177569 | 00887868271144 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | SEE H10 NARRATIVE. |