BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER STD

    MDR report key: 10225174 · Received July 2, 2020

    Report

    Report Number
    0002648920-2020-00331
    Event Type
    Injury
    Date Received
    July 2, 2020
    Date of Event
    June 18, 2020
    Report Date
    October 16, 2020
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K960658
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. PATIENT FELL DUE TO DEVELOPMENT OF SCIATICA THAT WAS AFFECTING THE LEFT LEG (THE NON OPERATIVE LEG). THIS IS A PT ANATOMY/ PT COMORBIDITY ISSUE THAT IS NOT DEVICE OR PROCEDURE RELATED AS IT DEVELOPED MONTHS POSTOPERATIVELY, THE PROSTHESIS DOES NOT COME IN CONTACT WITH THE SCIATIC NERVE, AND IT WAS THE CONTRALATERAL/OPPOSITE LEG THAT WAS AFFECTED. SCIATICA REFERS TO PAIN THAT RADIATES ALONG THE PATH OF THE SCIATIC NERVE, WHICH BRANCHES FROM YOUR LOWER BACK THROUGH YOUR HIPS AND BUTTOCKS AND DOWN EACH LEG. TYPICALLY, SCIATICA AFFECTS ONLY ONE SIDE OF YOUR BODY. SCIATICA MOST COMMONLY OCCURS WHEN A HERNIATED DISK, BONE SPUR ON THE SPINE OR NARROWING OF THE SPINE (SPINAL STENOSIS) COMPRESSES PART OF THE NERVE. THIS CAUSES INFLAMMATION, PAIN AND OFTEN SOME NUMBNESS IN THE AFFECTED LEG THAT OFTEN TIMES CAUSES THE LEG TO GIVE OUT.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE : (B)(6). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 010000707, LOT NUMBER:3956515, BRAND NAME: G7 BONEMASTER SHELL. CATALOG NUMBER:110003628, LOT NUMBER:3883478, BRAND NAME: BIOLOX DELTA CERAMIC LINER. CATALOG NUMBER: 00877503603, LOT NUMBER:3001638, BRAND NAME: BIOLOX DELTA CERAMIC HEAD. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THAT THE PATIENT FELL FROM A STANDING POSITION AND REQUIRED HOSPITALIZATION. THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH A PLATE PLACEMENT DUE TO PERIPROSTHETIC FRACTURE APPROXIMATELY 7 MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690627 FEMORAL STEM 12/14 NECK TAPER STD PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 63456955

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R