BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE E1 INSERT DIAMETER 28 SIZE 54

    MDR report key: 8473622 · Received April 2, 2019

    Report

    Report Number
    3006946279-2019-00203
    Event Type
    Injury
    Date Received
    April 2, 2019
    Date of Event
    March 11, 2019
    Report Date
    September 6, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDI
    UDI-DI
    03599870097731
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCT : ITEM : 00-8775-028-01, NAME : 12/14 CERAMIC FEMORAL HEAD - 3.5X28, INVESTIGATED IN (B)(4), LOT : 2834438. ITEM : P0460P54, NAME : AVANTAGE RELOAD CUP TI HA S54, LOT : 0100121030. ITEM : 0001104629, NAME : STEM, LOT : 2847140. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED. HOWEVER, X-RAYS AND PICTURES HAVE BEEN RECEIVED. X-RAYS REVIEW SHOWS THAT THE HEAD AND THE INSERT ARE DISLOCATED. PICTURES RECEIVED SHOWS THAT THE INSERT IS CRACKED ON SEVERAL AREAS AROUND THE INSERTED PART. THE REPORTED EVENT WAS CONFIRMED. THE REVIEW OF THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT 24 PRODUCTS AVANTAGE E1 INSERT 28 S54, REFERENCE P0561E54, BATCH 0001202087 WERE MANUFACTURED ON 23 FEBRUARY 2017. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO NON CONFORMITY OR DEVIATION WAS OBSERVED WHICH COULD BE LINKED TO THE COMPLAINT ISSUE. NO OTHER COMPLAINT ON THE ISSUE HAS BEEN RECORDED FOR AVANTAGE E1 INSERT D28 SIZE 54, REFERENCE P0561E54, BATCH 0001202087 WITHIN ONE YEAR. AN INVESTIGATION HAS BEEN PERFORMED, CONSISTING OF A DOCUMENTARY REVIEW. THE DOCUMENTARY REVIEW SHOWED THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS OF BIOMET FRANCE. X-RAYS REVIEW SHOWS THAT THE HEAD AND THE INSERT ARE DISLOCATED. PICTURES RECEIVED SHOWS THAT THE INSERT IS CRACKED ON SEVERAL AREAS AROUND THE INSERTED PART. ACCORDING TO AVAILABLE DATA, THE EXACT ROOT CAUSE CAN¿T BE DETERMINED. A LETTER CONVEYING ZIMMER BIOMET CONCLUSIONS WAS SENT TO THE COMPLAINANT. 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. MEDICAL PRODUCT : ITEM : 00-8775-028-01, NAME : 12/14 CERAMIC FEMORAL HEAD - 3.5X28, LOT : 2834438. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCT : ITEM : 00-8775-028-01, NAME : 12/14 CERAMIC FEMORAL HEAD - 3.5X28, LOT : 2834438. ITEM : P0460P54, NAME : AVANTAGE RELOAD CUP TI HA S54, LOT : 0100121030. ITEM : 0001104629, NAME : STEM, LOT : 2847140. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2019 A REVISION OF THE AVANTAGE CEMENTLESS INSERT WAS PERFORMED, SINCE THE HEAD WAS SEPARATED FROM THE INSERT. THE IMPLANT THAT WAS EXPLANTED DOES NOT SEEM DAMAGED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON MAR 11, 2019 A REVISION OF THE AVANTAGE CEMENTLESS INSERT WAS PERFORMED, SINCE THE HEAD WAS SEPARATED FROM THE INSERT. THE IMPLANT THAT WAS EXPLANTED DOES NOT SEEM DAMAGED. THE EXPLANT IS NOT AVAILABLE TO BE RETURN SINCE IT IS HOLD BY THE PATIENT FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ON (B)(6) 2019 A REVISION OF THE AVANTAGE CEMENTLESS INSERT WAS PERFORMED, SINCE THE HEAD WAS SEPARATED FROM THE INSERT. THE IMPLANT THAT WAS EXPLANTED DOES NOT SEEM DAMAGED. THE EXPLANT IS NOT AVAILABLE TO BE RETURN SINCE IT IS HOLD BY THE PATIENT FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019 A REVISION OF THE AVANTAGE CEMENTLESS INSERT WAS PERFORMED, SINCE THE HEAD WAS SEPARATED FROM THE INSERT. THE IMPLANT THAT WAS EXPLANTED DOES NOT SEEM DAMAGED. THE EXPLANT IS NOT AVAILABLE TO BE RETURN SINCE IT IS HELD BY THE PATIENT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268400 AVANTAGE E1 INSERT DIAMETER 28 SIZE 54 NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER JDI BIOMET FRANCE S.A.R.L. N/A 0001202087 03599870097731

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R