BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD MOD HD 32MM -3NK

    MDR report key: 12406666 · Received September 1, 2021

    Report

    Report Number
    3002806535-2021-00371
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    June 21, 2021
    Report Date
    October 13, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868248436
    PMA / PMN Number
    K042091
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEM. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY A CORRECTION. THE CORRECT LOT NUMBER HAS BEEN IDENTIFIED: LOT #2983186. 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 THE PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED ON (B)(6) 2021. ONE WEEK POSTOP, THE PATIENT DEVELOPED PNEUMONIA AND WAS HOSPITALIZED FOR ONE WEEK. TWO WEEKS LATER, THE PATIENT DEVELOPED A DVT AND WAS TREATED IN THE HOSPITAL OVERNIGHT. BY THE ONE MONTH VISIT, THE PATIENT REPORTED HIGH SATISFACTION WITH ONLY SLIGHT PAIN AND PROBLEMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED (B)(6) 2021. ONE WEEK POSTOP, THE PATIENT DEVELOPED PNEUMONIA AND WAS HOSPITALIZED FOR ONE WEEK. TWO WEEKS LATER, THE PATIENT DEVELOPED A DVT AND WAS TREATED IN THE HOSPITAL OVERNIGHT. BY THE ONE MONTH VISIT, THE PATIENT REPORTED HIGH SATISFACTION WITH ONLY SLIGHT PAIN AND PROBLEMS.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT: IMPLANT REMAINS IMPLANTED. ASSOCIATED PRODUCTS: MEDICAL PRODUCT: G7 PPS LTD ACET SHELL 50D, CATALOG #: 010000662, LOT #: 7001780. MEDICAL PRODUCT: G7 NEUTRAL ARCOMXL LNR 32MM D, CATALOG #: 010000731, LOT #: 6628977. MEDICAL PRODUCT: TPRLC XR FP TYPE1 PPS 7X134MM, CATALOG #: 51-102070, LOT #: 6945473. 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 THE PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED (B)(6) 2021. ONE WEEK POSTOP, THE PATIENT DEVELOPED PNEUMONIA AND WAS HOSPITALIZED FOR ONE WEEK. TWO WEEKS LATER, THE PATIENT DEVELOPED A DVT AND WAS TREATED IN THE HOSPITAL OVERNIGHT. BY THE ONE MONTH VISIT, THE PATIENT REPORTED HIGH SATISFACTION WITH ONLY SLIGHT PAIN AND PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308652 CER BIOLOXD MOD HD 32MM -3NK HIP PROTHESIS LZO BIOMET UK LTD. N/A 2983186 00887868248436

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization SEE H10 NARRATIVE