BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 36MM

    MDR report key: 14369242 · Received May 12, 2022

    Report

    Report Number
    3002806535-2022-00240
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    February 4, 2017
    Report Date
    May 27, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271397
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR INITIAL REPORT. PRODUCT REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: ITEM #010000938, LOT #3123575, G7 HI-WALL E1 LINER 36MM H; ITEM #010000669, LOT #3350575, G7 PPS LTD ACET SHELL 64H; ITEM #010000999, LOT #3365486, G7 SCREW 6.5MM X 30MM; ITEM #010000999, LOT #3369626, G7 SCREW 6.5MM X 30MM; ITEM #103207, LOT #220990, TAPERLOC POR FMRL 13.5X147; ITEM #650-1068, LOT # 3123575, CER OPTION TYPE 1 TPR SLEVE +6. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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 PRODUCT THE 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. THIS DEVICE IS USED FOR TREATMENT. A COMPATIBILITY CHECK CONFIRMS THERE ARE NO ISSUES. A REVIEW OF COMPLAINT HISTORY IDENTIFIED 2 ADDITIONAL SIMILAR COMPLAINTS ABOUT THE REPORTED ITEM AND NO ADDITIONAL COMPLAINTS ABOUT THE WRITTEN 1 OTHER WITH THE SAME ITEM AND LOT COMBINATION. X-RAYS WERE NOT PROVIDED. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO THE SPECIFICATION. THE REPORTED EVENT HAS NOT BEEN CONFIRMED AS RELEVANT PHOTOGRAPHS HAVE NOT BEEN PROVIDED, 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 IMPLANT IS NOT WITHIN THE SCOPE OR SUBJECT OF ANY FIELD ACTIONS OR RECALLS WHICH COULD BE ATTRIBUTED TO THE REPORTED EVENTS. CORRECTIVE OR PREVENTATIVE ACTION IS NOT REQUIRED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE TENDERED ACCORDINGLY IF ANY ADDITIONAL INFORMATION IS DISCOVERED OR RECEIVED THAT MAY ADJUST ANY CONCLUSIONS OR DATA. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN MEDICAL NOTES RECEIVED THAT PATIENT EXPERIENCED DISLOCATION APPROXIMATELY 5 MONTHS POST-IMPLANTATION. IT IS UNKNOWN IF MEDICAL INTERVENTION TOOK PLACE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT: THE PATIENT EXPERIENCED DISLOCATION APPROXIMATELY 5 MONTHS POST-IMPLANTATION¿PATIENT INVOLVEMENT- JOINT DISLOCATION IN MEDICAL NOTES RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2311729 CER BIOLOXD OPTION HD 36MM HIP PROTHESIS LZO BIOMET UK LTD. N/A 592710 00887868271397

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other SEE H10 COMMENTS