BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CER OPTION TYPE 1 TPR SLEVE +6

    MDR report key: 12851497 · Received November 22, 2021

    Report

    Report Number
    3002806535-2021-00507
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    November 15, 2021
    Report Date
    April 12, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271502
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY SUPPLEMENTAL INFORMATION. COMPLAINT SUMMARY: ADEQUATE PHOTOGRAPHS HAVE NOT BEEN PROVIDED AND THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION HAS BEEN LIMITED TO THE INFORMATION PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS, AND A COMPLAINT HISTORY SEARCH. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING THAT COULD BE RELATED TO THE REPORTED EVENT. THESE DEVICES ARE USED FOR TREATMENT. A COMPATIBILITY ASSESSMENT COULD NOT BE PERFORMED AS THE ASSOCIATED PRODUCTS ARE UNKNOWN. A REVIEW OF COMPLAINT HISTORY IDENTIFIED NO ADDITIONAL SIMILAR COMPLAINTS ABOUT THE REPORTED ITEM(650-1057 LOT. 2962672) AND NO ADDITIONAL COMPLAINTS ABOUT THE REPORTED ITEM AND LOT COMBINATION. A REVIEW OF COMPLAINT HISTORY IDENTIFIED 4 ADDITIONAL SIMILAR COMPLAINTS ABOUT THE REPORTED ITEM(650-1068 LOT. 2962695) AND NO ADDITIONAL COMPLAINTS ABOUT THE REPORTED ITEM AND LOT COMBINATION. THE LIKELY CONDITION OF THE DEVICES WHEN THEY LEFT ZIMMER BIOMET IS CONFORMING TO THE SPECIFICATION. THE REPORTED EVENT HAS NOT BEEN CONFIRMED AS RELEVANT PHOTOGRAPHS HAVE NOT BEEN PROVIDED AND THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AND THE DHR REVIEW DID NOT IDENTIFY ANY ISSUES. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IT HAS BEEN CONFIRMED THAT THE INSTRUMENT/IMPLANT IS NOT WITHIN THE SCOPE OR SUBJECT OF ANY FIELD ACTIONS OR RECALLS WHICH COULD BE ATTRIBUTED TO THE REPORTED EVENTS. CORRECTIVE ACTION AND/OR PREVENTATIVE ACTION: NO CORRECTIVE OR PREVENTIVE ACTION IS REQUIRED AT THIS TIME. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT NUMBERS: 3002806535-2021-00508-1. IF ANY ADDITIONAL INFORMATION IS DISCOVERED OR RECEIVED THAT MAY ADJUST ANY CONCLUSIONS OR DATA, A SUPPLEMENTAL REPORT WILL BE RENDERED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORT. CONCOMITANT MEDICAL PRODUCTS: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00506. 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: THE PATIENT HAD THE RIGHT TOTAL HIP REPLACED APPROXIMATELY 25 YEARS AGO IN (B)(6). ZIMMER 411 HELPED IDENTIFY LIKELY CUP STEMS MALLORY COMPONENTS. REVISION SURGERY WAS COMPLETED BY DR (B)(6) ON (B)(6) 2021 FOR OSTEOLYSIS AND PAIN IN THE RIGHT HIP. THE CUP AND STEM DID APPEAR TO BE MALLORY. CUP SAID 54 ON IT. THE HEAD WAS A 28 STD JUST SAID STD THAT WE COULD READ. NOTHING OFF THE LINER COULD BE READ. A RINGLOC REPLACEMENT LINER WAS USED SIZE 24. THE DOCTOR FIRST A TYPE ONE REVISION WITH CERAMIC HEAD (+6 SLEEVE AND 16/18 TAPER BIOLOX OPTION 36 HEAD). THE HEAD AND SLEEVE DID NOT APPEAR TO SIT DOWN AS FAR AS THE TRIAL HEAD. THE DOCTOR WAS HESITANT TO IMPACT AS THERE WAS CLOSE TO A 1CM GAP FROM THE END OF THE SLEEVE TO THE END OF THE STEM. THE DOCTOR THEN USED A +9 COCR TYPE ONE 36 HEAD AND IMPACTED. IT ALSO SEEMED TO SIT HIGH ON THE TRUNION. THE DOCTOR ASKED ME TO SEND THE SLEEVE AND NECK IN AND CONFIRM IT IS THE CORRECT SIZE FOR A TYPE ONE TAPER. PATIENT OUTCOME- REVISION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD RIGHT TOTAL HIP REPLACED APPROXIMATELY 25 YEARS AGO IN (B)(6). HEAD AND SLEEVE DID NOT APPEAR TO SIT DOWN AS FAR AS THE TRIAL HEAD. DR WAS HESITANT TO IMPACT AS THERE WAS CLOSE TO 1CM GAP FROM THE END OF THE SLEEVE TO THE END OF THE STEM. DR THEN USED A +9 COCR TYPE ONE 36 HEAD AND IMPACTED. IT ALSO SEEMED TO SIT HIGH ON THE TRUNION. THE DOCTOR HAS REQUESTED THAT THE HEAD AND SLEEVE BE CHECKED TO CONFIRM THEY ARE SUITABLE FOR A TYPE ONE TAPER. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748339 CER OPTION TYPE 1 TPR SLEVE +6 CER BIOLOXD OPT TYPE 1 TPR SLV LZO BIOMET UK LTD. N/A 2962695 00887868271502

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male