BIOLOX DELTA MODULAR CERAMIC FEM HD 36/-3MM
Report
- Report Number
- 3002806535-2024-00105
- Event Type
- Injury
- Date Received
- March 19, 2024
- Date of Event
- February 20, 2024
- Report Date
- July 17, 2024
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LZO
- PMA / PMN Number
- K192683
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED METAL TRANSFER TO THE CERAMIC HEAD WHICH COULD BE FROM BOTH THE DISLOCATION AND FROM THE INSTRUMENTS WHERE THE HEAD WAS ATTEMPTED TO BE REMOVED FROM THE STEM. THE HEAD IS STILL ATTACHED TO THE STEM AND THERE IS DAMAGE TO THE NECK OF THE STEM. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. A REVIEW OF THE RAW MATERIAL CERTIFICATE 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. IT SHOULD BE NOTED HOWEVER THAT THE SAME DEVICE IS INCLUDED IN AN ADDITIONAL COMPLAINT ON A POST-OP HEAD DISLOCATION AND REPORTED IN MFR 3002806535-2024-00104. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED THAT THERE IS A LEFT HIP ARTHROPLASTY WITH A SUPEROLATERAL DISLOCATION. THE FEMORAL HEAD IS ANTERIORLY DISPLACED ON THE CROSS-TABLE LATERAL VIEW, BUT THE CUP IS NOT WELL VISUALIZED. THERE IS NO FRACTURE. OTHER THAN THE DISLOCATION, NO OTHER IMPLANT FAILURE IS IDENTIFIED. THE CUP ABDUCTION ANGLE MEASURES APPROXIMATELY FIFTY-THREE DEGREES, AT THE UPPER LIMIT OF NORMAL. WITH THE AVAILABLE INFORMATION, 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). TPRLC 133 T1 PPS SO 20X160MM, ITEM# 51-103200, LOT#7244589. HXPE LINER NEUT 58 LL X 36, ITEM# 00-8751-013-36, LOT# 65501354. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. 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, H1, H2, H3, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: H6. FEMORAL HEAD IMPLANTS' TAPER FEATURE AND FEMORAL STEMS' TRUNNIONS ARE DESIGNED TO ACHIEVE STABLE, LONG-TERM FIXATION. SINCE THE TAPER OF THE STEM AND THE HEAD ARE DESIGNED FOR LONGEVITY, THE FACT THAT THE HEAD AND STEM WERE WELL CONNECTED IS A DESIRED DESIGN ASPECT OF THE PRODUCT. NO PRODUCT ISSUE HAS BEEN IDENTIFIED. 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. SHOW LESS
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED DURING THE REVISION, THAT THE STEM WOULD NOT DISENGAGE FROM THE HEAD. THE STEM AND THAT HEAD WERE REMOVED AND NEW ONES WERE USED TO COMPLETE THE PROCEDURE. THE APPROXIMATE SURGICAL DELAY WAS AROUND NINETY MINUTES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2324508 | BIOLOX DELTA MODULAR CERAMIC FEM HD 36/-3MM | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER | LZO | BIOMET UK LTD. | N/A | 3159543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | SEE H10 NARRATIVE |