BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE INLAY S48 / 22,2

    MDR report key: 8951310 · Received August 30, 2019

    Report

    Report Number
    3006946279-2019-00380
    Event Type
    Injury
    Date Received
    August 30, 2019
    Date of Event
    July 2, 2018
    Report Date
    December 12, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LPH
    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 ITEM P0560048 / LOT 0001102705 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 ON (B)(6) 2017 DUE TO LEFT FEMORAL NECK FRACTURE. AVANTAGE CEMENTED SHELL, AVANTAGE 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. FOR THIS EVENT AVANTAGE CEMENTED SHELL Ø48MM (HANDLE IN (B)(4)), AVANTAGE INLAY S48 (HANDLE IN (B)(4)), OPTIPAC-S 60 REFOBACIN BONE CEMENT LOT A710B05615 (HANDLE IN (B)(4)) AND LOT B708C06355 (HANDLE IN (B)(4)), FEMORAL STEM 12/14 (HANDLE IN (B)(4)) AND FEMORAL HEAD STERILE 12/14 (HANDLE IN (B)(4)). SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2018 DUE TO RECURRENT DISLOCATIONS, INSTABILITY, AND IMPINGEMENT. DURING THE REVISION, A HEMATOMA WAS NOTED AS WELL AS AN ABSENT POSTERIOR JOINT CAPSULE. THE AVANTAGE CEMENTED SHELLØ48MM WAS LEFT IN PLACE (INVESTIGATED IN (B)(4)). THE STEM (INVESTIGATED IN (B)(4)) AND FEMORAL HEAD (INVESTIGATED IN (B)(4)) WERE REPLACED WITH A COMPETITOR PRODUCT, AND THE BEARING (INVESTIGATED IN THE CURRENT COMPLAINT (B)(4)) WAS REPLACED BY THE AVANTAGE INLAY S48 / 28. THE OPTIPAC-S 60 REFOBACIN BONE CEMENT LOT B708C06355 HAS BEEN INVESTIGATED IN (B)(4) AND THE OPTIPAC-S 60 REFOBACIN BONE CEMENT LOT A710B05615 HAS BEEN 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.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CONCOMITANT MEDICAL PRODUCTS- AVANTAGE CEMENTED CUP; ITEM: P0463048; LOT: 0001105980; OPTIPAC-S 60 REFOBACIN BONE CEMENT R, ITEM: 4711500396-1; LOT: A710B05615; OPTIPAC-S 60 REFOBACIN BONE CEMENT R, ITEM: 4711500396-1; LOT: B708C0535;5 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 WAS REVISED ON (B)(6) 2018 DUE TO RECURRENT DISLOCATIONS, INSTABILITY, AND IMPINGEMENT. DURING THE REVISION, A HEMATOMA WAS NOTED AS WELL AS AN ABSENT POSTERIOR JOINT CAPSULE. THE AVANTAGE CEMENTED SHELLØ48MM WAS LEFT IN PLACE. THE STEM AND FEMORAL HEAD WERE REPLACED WITH A COMPETITOR PRODUCT, AND THE BEARING WAS REPLACED BY THE AVANTAGE INLAY S48 / 28.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745615 AVANTAGE INLAY S48 / 22,2 PROSTHESIS, HIP LPH BIOMET FRANCE S.A.R.L. N/A 0001102705

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R