BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC-S 60 REFOBACIN BONE CEMENT R

    MDR report key: 13382068 · Received January 28, 2022

    Report

    Report Number
    3006946279-2022-00009
    Event Type
    Injury
    Date Received
    January 28, 2022
    Date of Event
    December 1, 2020
    Report Date
    February 10, 2022
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    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: PSN ASF CR 10MM PLY L 3-11 EF, REFERENCE 42-5110-005-10, BATCH 63535021; PSN TIB STM 5 DEG SZ F L, REFERENCE 42-5320-075-01, BATCH 63560762; PSN FEM CR CMT CCR STD SZ 11 L, REFERENCE 42-5026-070-01, BATCH 63567263; PSN ALL POLY PAT PLY 38MM, REFERENCE 42-5400-000-38, BATCH 64100059. REPORT 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). LIST OF ASSOCIATED DEVICES: PSN ASF CR 10MM PLY L 3-11 EF, REFERENCE 42-5110-005-10, BATCH 63535021; PSN TIB STM 5 DEG SZ F L, REFERENCE 42-5320-075-01, BATCH 63560762; PSN FEM CR CMT CCR STD SZ 11 L, REFERENCE 42-5026-070-01, BATCH 63567263; PSN ALL POLY PAT PLY 38MM, REFERENCE 42-5400-000-38, BATCH 64100059. REPORT 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. THE REVIEW OF THE MEDICAL RECORDS BY THE HOSPITAL SHOWED THAT THE INFECTION WAS DUE TO STAPHYLOCOCCUS LUGDUNENSIS AND IS A COMMENSAL BACTERIA ON HUMAN SKIN. 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. THE REVIEW OF THE STERILIZATION CERTIFICATE INDICATES THAT THE PRODUCTS WERE STERILIZED ACCORDING TO THE SPECIFICATION. A COMPLAINT EXTRACT WAS DONE REGARDING REVISION DUE TO INFECTION: 5 COMPLAINTS (5 PRODUCTS), THIS ONE INCLUDED, HAVE BEEN RECORDED ON OPTIPAC 60 REFOBACIN BONE CEMENT R-1, REFERENCE (B)(4), FROM (B)(6), 2019 TO (B)(6), 2022. 1 COMPLAINT (1 PRODUCT), THIS ONE INCLUDED, HAS BEEN RECORDED ON OPTIPAC 60 REFOBACIN BONE CEMENT R-1, REFERENCE (B)(4), BATCH A747C07115. 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 THROUGH A CLINICAL STUDY THAT A PATIENT UNDERWENT A PRIMARY TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2020 DATE DUE TO DEEP INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A CLINICAL STUDY THAT A PATIENT UNDERWENT A PRIMARY TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2020 DATE DUE TO DEEP INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A CLINICAL STUDY THAT A PATIENT UNDERWENT A PRIMARY TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2020 DATE DUE TO DEEP INFECTION. THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO SWELLING OF THE KNEE AFTER HEAVY WORK, PAIN IN THE MEDIAL COMPARTMENT WAS OBSERVED AND IT WAS NOT POSSIBLE TO EXAMINE THE STABILITY OF THE KNEE, AFTER A KNEE PUNCTURE STAPHYLOCOCCUS LUGDUNENSIS WERE DETECTED, DUE TO THIS REVISION IN TWO STAGES WAS PERFORMED. ALL BONE ATTACHED COMPONENTS WERE WELL PLACED AND THE INSERT DID NOT HAVE ANY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46379 OPTIPAC-S 60 REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. A747C07115

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention ASSOCIATED DEVICES LISTED IN H10.