BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC 80 BIOMET BC R

    MDR report key: 21430160 · Received February 21, 2025

    Report

    Report Number
    3006946279-2025-00023
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    December 27, 2024
    Report Date
    May 20, 2025
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 ¿ 3553.102, CMK-STEM CEM MOD 12/14 SIZE102, LOT 0001854675. 31-479552, BIPOLAR/ENDO PROV CUP 28X42MM, LOT UNKNOWN. G2 ¿ FOREIGN ¿ 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.

    Additional Manufacturer Narrative · 0

    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: D4, G1-2. D4 - PRIMARY DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN. D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). 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 K172408. H11 - ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT CARDIAC RESUSCITATION DURING THE IMPLANTATION OF A CEMENTED FEMORAL STEM. SURGERY WAS ABORTED WITH STEM AND CUP IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706369 OPTIPAC 80 BIOMET BC R BONE CEMENT LOD BIOMET FRANCE S.A.R.L. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.