BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC-S 60 REFOBACIN BONE CEMENT R

    MDR report key: 9486362 · Received December 18, 2019

    Report

    Report Number
    3006946279-2019-00541
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    January 3, 2018
    Report Date
    December 5, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    03599870112229
    PMA / PMN Number
    K150850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) REPORT SOURCE, FOREIGN EVENT OCCURRED IN (B)(6). CONCOMITANT MEDICAL PRODUCTS: ADVANTAGE CEMENTED SHELL SS Ø48MM; ITEM: P0463048; LOT: 0001105980 (INVESTIGATED IN (B)(4)). ADVANTAGE INLAY S48 / 22,2; ITEM: P0560048; LOT: 0001102705 (INVESTIGATED IN (B)(4)). OPTIPAC-S 60 REFOBACIN BONE CEMENT R ITEM: 4711500396-1 LOT: A710B05615 (INVESTIGATED IN (B)(4)). FEMORAL STEM 12/14 ITEM: 00811400100; LOT: 63735436 (INVESTIGATED IN (B)(4)). FEMORAL HEAD STERILE 12/14 ITEM: 00801802230 AND LOT: 63677745 (INVESTIGATED IN (B)(4)). INTRAMEDULLARY PLUG ITEM 02994000 / LOT 172102309 (NOT A ZIMMER BIOMET PRODUCT). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED. NO FURTHER INFORMATION PROVIDED (X-RAYS, SURGICAL REPORT, PHOTOGRAPHS, LAB TEST). THE REPORTED EVENT COULD NOT BE CONFIRMED. THE REVIEW OF THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT 2248 PRODUCTS OPTIPAC-S 60 REFOBACIN BONE CEMENT R, REFERENCE (B)(4) LOT NUMBER B708C06355 WERE MANUFACTURED ON DATE 22 MARCH 2017. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES 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. NO NON CONFORMITY OR DEVIATION WAS OBSERVED WHICH COULD BE LINKED TO THE EVENT DESCRIBED IN THE COMPLAINT. NO OTHER SIMILAR COMPLAINT HAS BEEN RECORDED FOR OPTIPAC-S 60 REFOBACIN BONE CEMENT R, REFERENCE (B)(4) LOT NUMBER B708C06355 ON THE REPORTED EVENT WITHIN ONE YEAR. WITH THE AVAILABLE INFORMATION, THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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 · 1

    IT WAS REPORTED THAT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2017 DUE TO LEFT FEMORAL NECK FRACTURE. ADVANTAGE CEMENTED SHELL, ADVANTAGE INLAY, OPTIPAC-S 60 REFOBACIN BONE CEMENT, FEMORAL STEM, FEMORAL HEAD STERILE AND INTRAMEDULLARY PLUG WERE IMPLANTED. 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. WOUND COMPLICATION LASTED UNTIL MID-FEBRUARY AS PER PATIENT. THIS EVENT IS INVESTIGATED IN THE CURRENT COMPLAINT FOR THE OPTIPAC-S 60 REFOBACIN BONE CEMENT LOT B708C06355. SUBSEQUENTLY, THE PATIENT WAS REVISED ON 02 JULY 2018 DUE TO RECURRENT DISLOCATIONS, INSTABILITY, AND IMPINGEMENT (INVESTIGATED IN (B)(4)). ON (B)(6) 2018, THE PATIENT UNDERWENT A STAGE 1 REVISION OF ALL COMPONENTS WITH IMPLANTATION OF AN ANTIBIOTIC SPACER DUE TO FEMORAL PERIPROSTHETIC FRACTURE AND CONCURRENT INFECTION (INVESTIGATED IN (B)(4)). THE SPACER WAS REMOVED DURING THE STAGE 2 REVISION ON (B)(6) 2019. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281855 OPTIPAC-S 60 REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. B708C06355 03599870112229

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R