BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC-S 60 REFOBACIN BONE CEMENT R

    MDR report key: 8951657 · Received August 30, 2019

    Report

    Report Number
    3006946279-2019-00385
    Event Type
    Injury
    Date Received
    August 30, 2019
    Date of Event
    January 3, 2018
    Report Date
    November 22, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    K150850
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B5, G4, H10. DURING THE INVESTIGATION, IT HAS BEEN NOTICED THAT THE PRODUCT 4711500396-1 / LOT B708C05355 IS HANDLED BY (B)(4). THE MEDWATCH REPORT FOR THIS PRODUCT WILL BE SUBMITTED IN (B)(4). 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 AN INITIAL LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH IMPLANTATION OF AN AVANTAGE CEMENTED SHELL Ø48MM, AVANTAGE INLAY S48, OPTIPAC-S 60 REFOBACIN BONE CEMENT, FEMORAL STEM (B)(6), FEMORAL HEAD STERILE (B)(6) AND INTRAMEDULLARY PLUG ON (B)(6) 2017. SUBSEQUENTLY, THE PATIENT EXPERIENCED REDNESS AND DRAINAGE FROM THE SURGICAL SITE, WAS PLACED ON PROPHYLACTIC ANTIBIOTICS, AND WAS ADMITTED FOR OBSERVATION TO RULE OUT INFECTION. INFECTION WAS RULED OUT, AND THE DRAINAGE DISCONTINUED WITHOUT FURTHER COMPLICATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CONCOMITANT MEDICAL PRODUCTS: AVANTAGE CEMENTED SHELL S48, ITEM: P0463048, LOT: 0001105980; AVANTAGE INLAY S48 / 22,2, ITEM: P0560048, LOT: 0001102705; OPTIPAC-S 60 REFOBACIN BONE CEMENT R, ITEM: 4711500396-1, LOT: A710B05615; FEMORAL STEM 12/14, ITEM: 00811400100; LOT: 63735436; FEMORAL HEAD STERILE 12/14, ITEM: 00801802230, AND LOT: 63677745. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH IMPLANTATION OF AN AVANTAGE CEMENTED SHELL Ø48MM, AVANTAGE INLAY S48, OPTIPAC-S 60 REFOBACIN BONE CEMENT, FEMORAL STEM 12/14 AND FEMORAL HEAD STERILE 12/14 ON (B)(6) 2017. SUBSEQUENTLY, THE PATIENT EXPERIENCED REDNESS AND DRAINAGE FROM THE SURGICAL SITE, WAS PLACED ON PROPHYLACTIC ANTIBIOTICS, AND WAS ADMITTED FOR OBSERVATION TO RULE OUT INFECTION. INFECTION WAS RULED OUT, AND THE DRAINAGE DISCONTINUED WITHOUT FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745015 OPTIPAC-S 60 REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A B708C05355

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R