BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC 80 REFOBACIN REVISION

    MDR report key: 13333101 · Received January 24, 2022

    Report

    Report Number
    3006946279-2022-00008
    Event Type
    Injury
    Date Received
    January 24, 2022
    Date of Event
    February 28, 2013
    Report Date
    February 10, 2022
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A COMBINATION PRODUCT (B)(4). LIST OF ASSOCIATED DEVICES: LCCK FEM IMPLANT SZ C-RT, REFERENCE 00-5994-013-92, BATCH 61522741. NG A/P WGD PRCT TIB PLT SZ 4, REFERENCE 00-5988-004-00, BATCH 61916850. LCCK ART SURF CD 3-4/YEL 17, REFERENCE 00-5994-030-17, BATCH 61903523. GREPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS IS A COMBINATION PRODUCT (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO FURTHER INFORMATION PROVIDED (X-RAYS, SURGICAL REPORT, PHOTOGRAPHS, LAB TEST). THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE PRODUCT ANALYSIS CAN'T BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. A COMPLAINT EXTRACT WAS DONE REGARDING REVISION DUE TO PAIN AND LOOSENING: 3 COMPLAINTS (3 PRODUCTS), THIS ONE INCLUDED, HAVE BEEN RECORDED ON OPTIPAC 80 REFOBACIN REVISION, REFERENCE 4732501165, FROM (B)(6) 01, 2018 TO (B)(6) 2022. 1 COMPLAINT (1 PRODUCT), THIS ONE INCLUDED, HAS BEEN RECORDED ON OPTIPAC 80 REFOBACIN REVISION, REFERENCE 4732501165, BATCH 126AAD0405. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. HOWEVER, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO THE PRODUCT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RETROSPECTIVE STUDY OF THE NEXGEN AP WEDGE TIBIAL PROSTHESIS PATIENT UNDERWENT AN INITIAL IMPLANT OF (B)(6) 2012. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION PROCEDURE ON (B)(6) 2015 DUE TO PAIN AND LOOSENING. THE PI LISTED THE EVENT AS UNCERTAINLY RELATED TO THE INSTRUMENT, UNCERTAINLY RELATED TO THE DEVICE AND PROBABLY RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RETROSPECTIVE STUDY OF THE NEXGEN AP WEDGE TIBIAL PROSTHESIS PATIENT UNDERWENT AN INITIAL IMPLANT OF (B)(6) 2012. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION PROCEDURE ON (B)(6) 2015 DUE TO PAIN AND LOOSENING. THE PI LISTED THE EVENT AS UNCERTAINLY RELATED TO THE INSTRUMENT, UNCERTAINLY RELATED TO THE DEVICE AND PROBABLY RELATED TO THE PROCEDURE. NO POSSIBLY CONTRIBUTING FACTORS ARE MENTIONED IN MEDICAL NOTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949168 OPTIPAC 80 REFOBACIN REVISION BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. 126AAD0405

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention ASSOCIATED DEVICES LISTED IN H10.