BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE CEMENTED SHELL SS Ø48MM

    MDR report key: 8951771 · Received August 30, 2019

    Report

    Report Number
    3006946279-2019-00375
    Event Type
    Injury
    Date Received
    August 30, 2019
    Date of Event
    January 3, 2018
    Report Date
    December 10, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDI
    UDI-DI
    03599870013083
    PMA / PMN Number
    N/A
    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, D4, D10, G4, H2, H3, H4, H6, H10 D11- CONCOMITANT MEDICAL PRODUCTS AVANTAGE 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)). OPTIPAC-S 60 REFOBACIN BONE CEMENT R ITEM: 4711500396-1 LOT: B708C05355 (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. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE REVIEW OF THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT 12 PRODUCTS AVANTAGE CEMENTED CUP S48, REFERENCE P0463048, BATCH 0001105980 WERE MANUFACTURED ON 24 MARCH 2016. 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 COMPLAINTS HAVE BEEN RECORDED FOR AVANTAGE CEMENTED CUP S48, REFERENCE P0463048, BATCH 0001105980 REGARDING THIS 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS AVANTAGE 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). OPTIPAC-S 60 REFOBACIN BONE CEMENT R ITEM: 4711500396-1 LOT: B708C06355 (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 PICTURES OR X-RAYS HAVE BEEN RECEIVED. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE REVIEW OF THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT 12 PRODUCTS AVANTAGE CEMENTED CUP S48, REFERENCE: (B)(4), BATCH: 0001105980 WERE MANUFACTURED ON 24 MARCH 2016. 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 COMPLAINTS HAVE BEEN RECORDED FOR AVANTAGE CEMENTED CUP S48, REFERENCE: (B)(4), BATCHZ; 0001105980 REGARDING THIS 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 · 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 12/14, FEMORAL HEAD STERILE 12/14 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.

    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. THIS EVENT IS INVESTIGATED IN THE CURRENT COMPLAINT. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 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.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CONCOMITANT MEDICAL PRODUCTS: AVANTAGE INLAY S48 / 22,2, ITEM: P0560048, LOT: 0001102705; OPTIPAC-S 60 REFOBACIN BONE CEMENT R, ITEM: 4711500396-1, LOT: A710B05615; OPTIPAC-S 60 REFOBACIN BONE CEMENT R, ITEM: 4711500396-1, LOT: B708C05355; 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 17TH (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
    742504 AVANTAGE CEMENTED SHELL SS Ø48MM PROSTHESIS, HIP JDI BIOMET FRANCE S.A.R.L. 0001105980 03599870013083

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R