BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 11CM DIAPHYSEAL SEGMENT

    MDR report key: 7790075 · Received August 16, 2018

    Report

    Report Number
    0001825034-2018-08159
    Event Type
    Injury
    Date Received
    August 16, 2018
    Date of Event
    July 20, 2018
    Report Date
    May 6, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: OSS 11CM DIAPHYSEAL SEGMENT; P/N: 150468, L/N: 306080. OSS 7CM SEGMENTAL FEMORAL; P/N: 150355, L/N: 0000291872. OSS CEMENTED IM STEM; P/N: 150367, L/N: 405580. BEARING; P/N: UNK, L/N: 089700. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF DIAPHYSEAL SEGMENT REVEALS A FRACTURE THAT LEFT A PART OF SEGMENT EMBEDDED IN THE FEMORAL COMPONENT. VISUAL INSPECTION OF FEMORAL COMPONENT SHOWS THAT A SMALL PIECE CRACKED OFF THE TAB. BOTH COMPONENTS SHOW NICKS AND DINGS AND SCRATCHES ON THE EXTERNAL SURFACE. SEM ANALYSIS FOR THE DIAPHYSEAL SEGMENT STATES THAT THE FRACTURE WAS A FATIGUE FRACTURE. THE 11.0CM SEGMENT HAS NUMEROUS SCRATCHES, DEFORMATIONS & OTHER POST-FRACTURE DAMAGE. THE XRF SCAN PHOTO IN VERIFIES THE SEGMENT¿S MATERIAL AS TI6-4 TITANIUM. THE FRACTURED PIECE OF THE DIAPHYSEAL SEGMENT WAS NOT DISASSEMBLED DURING THE ANALYSIS. SEM ANALYSIS FOR THE FEMORAL STATES THAT THE POST FRACTURE DAMAGE HAS OBLITERATED MOST VISIBLE FRACTURE ARTIFACTS MAKING A VISUAL ANALYSIS OF THE FEMORAL SEGMENT INCONCLUSIVE. THE 7CM FEMORAL SEGMENT HAS NUMEROUS SCRATCHES, DEFORMATIONS & OTHER POST-FRACTURE DAMAGE. X-RAY EVALUATION PROVIDED BY THIRD PARTY HCP STATES THAT THE FRACTURE OF THE FEMORAL COMPONENT AT THE JUNCTION OF THE FEMORAL STEM AND FEMORAL HEAD WITH MEDIAL DISPLACEMENT OF THE FEMORAL HEAD. PUNCTATE METALLIC HYPERDENSITIES WITHIN THE SOFT TISSUES SURROUNDING THE KNEE. DISTAL FEMORAL RESECTION WITH HETEROTOPIC OSSIFICATION NOTED POSTERIOR TO THE DISTAL FEMORAL DIAPHYSIS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08159 - 1; 0001825034 - 2019 - 01837.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OSS CEMENTED IM STEM 13X150; P/N: 150367, L/N: UNKNOWN; OSS 7CM SEGMENTAL FEMORAL LT; P/N: 150355, L/N: UNKNOWN. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION; DUE TO IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS AND 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 UNDERWENT INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT HAS SUFFERED AN IMPLANT FRACTURE WHICH A REVISION IS SCHEDULED FOR A LATER DATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632374 OSS 11CM DIAPHYSEAL SEGMENT PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 306080

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R