BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL, ALPHA INSERT, HOODED, II/32

    MDR report key: 10229367 · Received July 3, 2020

    Report

    Report Number
    0009613350-2020-00304
    Event Type
    Injury
    Date Received
    July 3, 2020
    Date of Event
    June 22, 2020
    Report Date
    February 19, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE.EVENT DESCRIPTION: PATIENT EXPERIENCED AN INTRAOPERATIVE COMPLICATION WHEN THE DURASUL LINER WOULD NOT LOCK INTO THE ALLOFIT SHELL. THE SURGERY WAS COMPLETED WITH A DIFFERENT LINER, THE NEXT DAY, AS THERE WAS NO ADDITIONAL LINER AVAILABLE DURING THE INITIAL SURGERY. ALLOFIT SHELL REMAINED IMPLANTED. PRODUCT EVALUATION:VISUAL EXAMINATION: THE COMPLAINED DURASUL ALPHA LINER WAS RETURNED FOR INVESTIGATION. THE MARKING ON THE RIM IS ALMOST NOT VISIBLE INDICATING THAT THE INSERT WAS PROBABLY AUTOCLAVED PRIOR OF ARRIVING AT ZIMMER BIOMET. OTHER THAN THAT, THE ARTICULATION SIDE OF THE INSERT IS INCONSPICUOUS. THE BACKSIDE SHOWS A CUT OFF POLE PLUG AND SLIGHT NON-CENTRICAL INDENTATIONS OF THE SHELL'S ANTI-ROTATION SPIKES.A COMBINATION OF WEAR AND DEFORMATION IN FORM OF LINES CAN BE OBSERVED BELOW THE INSERT'S RIM ON THE SPHERICAL AREA CLOSE TO THE RIM. THE DEFORMATION / WEAR POINTS TO CONTACT BETWEEN THE INSERT AND AN EDGE OF THE SHELL.MEASUREMENTS HAVE BEEN PERFORMED.REVIEW OF PRODUCT DOCUMENTATION:DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT.DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING.NCR(S): NO NCR WITH A POTENTIAL CORRELATION TO THE REPORTED EVENT WAS FOUND.SURGICAL TECHNIQUE:(IF THE LINER CAN STILL BE ROTATED AFTER LIGHT IMPACTION, THIS INDICATES MISPOSITIONING, NONCONCENTRIC, OR SOFT TISSUES INTERFERENCE BETWEEN THE LINER AND THE SHELL SURFACES.)(IF THE FITTING OF THE INSERT IS FAULTY, A NEW INSERT MUST BE USED. IF THE POLAR PEG IS DEFORMED, IT WILL NOT BE POSSIBLE TO ANCHOR THE INSERT CORRECTLY.)CONCLUSION:IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INTRAOPERATIVE COMPLICATION WHEN THE DURASUL LINER WOULD NOT LOCK INTO THE ALLOFIT SHELL. THE SURGERY WAS COMPLETED WITH A DIFFERENT LINER, THE NEXT DAY, AS THERE WAS NO ADDITIONAL LINER AVAILABLE DURING THE INITIAL SURGERY. ALLOFIT SHELL REMAINED IMPLANTED. BASED ON THE INVESTIGATION THE REPORTED EVENT CAN BE CONFIRMED.THE DEFORMATION / WEAR ON THE DURASUL ALPHA LINER AS WELL AS THE CUT OFF POLE PLUG MAY INDICATE THAT THE LINER WAS MISPOSITIONED, NONCONCENTRIC OR INTERFERED WITH SOFT TISSUE RESIDUES. THIS IS A COMMON COMPLICATION ALSO DESCRIBED IN THE APPLICABLE SURGICAL TECHNIQUE WHICH REQUIRES THE USE OF A NEW LINER. NEVERTHELESS, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED.THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB).THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED.ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4)..

    Description of Event or Problem · 0

    INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ALLOFIT ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 52/II; CATALOG#: 4245; LOT#: 3033113. THERAPY DATE: UNKNOWN . THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    DURING SURGERY THERE WAS AN INTRAOPERATIVE COMPLICATION AS THE LINER WOULD NOT LOCK INTO THE SHELL. THE SURGERY WAS COMPLETED WITH A DIFFERENT LINER ON THE FOLLOWING DAY AS THERE WERE NO ADDITIONAL LINER AVAILABLE DURING SURGERY. REPORTED SURGICAL DELAY IS 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694784 DURASUL, ALPHA INSERT, HOODED, II/32 DURASUL, ALPHA INSERT, HOODED KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3019874

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10 NARRATIVE.