BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASUL LINERS

    MDR report key: 19259340 · Received May 7, 2024

    Report

    Report Number
    0009613350-2024-00159
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    April 26, 2024
    Report Date
    October 1, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    UDI-DI
    00889024413627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: REPORT SOURCE GERMANY. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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. THE FOLLOWING SECTIONS WERE UPDATED: B4, D9, D10, G3, G6, H2, H3, H6, H11. D10: ITEM # 4245, ALLOFIT ALLOCLAS SHELL 52/II, LOT # 3193678; ITEM # 0106010104, AVENIR MULLER STEM 4 LATERAL, LOT # 3168063; ITEM # 00877503602, BIOLOX DELTA HEAD 12/14 36X0, LOT # 3181540. THE INSERT WAS RETURNED FOR INVESTIGATION; HOWEVER THE SHELL WAS LEFT IMPLANTED. THE FLAT RIM AND THE INNER SURFACE OF THE INSERT SHOWS SOME SCRATCHES BUT OVERALL ARE INCONSPICUOUS. ON THE BACKSIDE OF THE INSERT, IT IS POSSIBLE TO SEE A SERIES OF LONG ABRASIONS. IT IS NOT POSSIBLE TO IDENTIFY THE THREE INDENTATION POINTS TYPICALLY PRODUCED IN THE POLYETHYLENE BY THE THREE METAL SPIKES OF THE SHELL. THE PEG IS SLIGHTLY FLATTENED AND DEFORMED WITH A NEWLY FORMED LEDGE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. SURGICAL TECHNIQUE INDICATES THAT THE SIZE OF THE INSERT IS INDICATED BY A LETTER CODE AND NEEDS TO MATCH THE SIZE ON THE CORRESPONDING SHELL. BONE OR SOFT TISSUE REMNANTS MUST NOT OVERLAP THE EDGE OF THE SHELL AS THEY MAY PREVENT THE INSERT FROM SNAPPING INTO POSITION; THEREFORE, IT IS RECOMMENDED TO CLEAN AND DRY THE INNER SURFACE OF THE SHELL BEFORE POSITIONING THE INSERT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. REVIEW OF THE MANUFACTURING RECORDS CONFIRMS THAT THE INSERT WAS PRODUCED ACCORDING TO SPECIFICATION; THEREFORE, IT IS NOT EXPECTED THAT THE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED EVENT. THE OBSERVATIONS MADE ON THE INSERT COULD POINT TO A POSSIBLE INITIAL MISPOSITIONING OF THE INSERT IN THE SHELL DURING IMPACTION. BASED ON THE AVAILABLE INFORMATION IT REMAINS UNKNOWN IF AND TO WHAT EXTEND A POSSIBLE INTERFERENCE BETWEEN THE INSERT AND THE SHELL DURING THE PROCEDURE MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE ESTABLISHED. 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 DURING THE PROCEDURE, THE LINER DID NOT ALLOW ITSELF TO BE KNOCKED. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT HAS NOT BEEN PROVIDED AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671651 DURASUL LINERS PROSTHESIS, HIP KWA ZIMMER GMBH N/A 3190395 00889024413627

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.