BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 32/-3.5, TAPER 12/14

    MDR report key: 10634675 · Received October 6, 2020

    Report

    Report Number
    0009613350-2020-00466
    Event Type
    Injury
    Date Received
    October 6, 2020
    Date of Event
    September 24, 2020
    Report Date
    November 2, 2020
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024430310
    PMA / PMN Number
    K071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON OCT 15, 2020. ADDITIONAL: B3. CORRECTION: B4, G4, G7, H2, H10. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    BASED ON INFORMATION PROVIDED FROM SURGEON THAT DERMABOND CAUSED INCISION WOUND EDGES TO BECOME NECROTIC REQUIRING MEDICAL INTERVENTION AND TREATMENT OF ANTIBIOTICS AS PREVENTIVE MEASURE; AND NO INDICATION OF IMPLANT INVOLVEMENT. THEREFORE THIS COMPLAINT WILL BE SET TO NOT-A-COMPLAINT AS THE PATIENT HAD REACTION TO ANOTHER MANUFACTURERS PRODUCT. THEREFORE THIS MDR IS OBSOLETE. PLEASE INVALIDATE THE CASE FROM YOUR SYSTEM. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON THE LEFT SIDE AND HAD TO UNDERGO A WOUND DEBRIDEMENT DUE TO A SUPERFICIAL INFECTION. PATIENT REPORTED SATISFACTION AND NO OTHER COMPLICATIONS.

    Description of Event or Problem · 0

    SEE H10.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: G7 PPS LTD ACETABULAR SHL 48C. CATALOG#: 010000661; LOT#: 6721216. LINER NEUTRAL 32 MM I.D. SIZE C FOR USE WITH G7 ACETABULAR SYSTEM ONLY. CATALOG#: 30103203; LOT#: 64669012. FEMORAL STEM CEMENTLESS COLLARED HIGH OFFSET 12/14 TAPER SIZE 4. CATALOG#: 574202040; LOT#: 3012866. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. 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

    PATIENT WAS IMPLANTED ON THE LEFT SIDE AND HAD TO UNDERGO A WOUND DEBRIDEMENT DUE TO A SUPERFICIAL INFECTION. PATIENT REPORTED SATISFACTION AND NO OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102965 BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 32/-3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3013059 00889024430310

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization SEE H10 NARRATIVE.