BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDUCED SIZE SCREW EXPANDABLE LEFT DISTAL FEMORAL 20CM REPLACEMENT

    MDR report key: 11574103 · Received March 26, 2021

    Report

    Report Number
    0001825034-2021-00904
    Event Type
    Injury
    Date Received
    March 26, 2021
    Date of Event
    February 17, 2021
    Report Date
    July 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    CUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWS THAT COMPONENTS CP-11-1829-01 AND CP-11-1343-03 TO BE FRACTURED AND SIGNS OF BEING IMPLANTED FOR 7 YEARS, WEAR AND BIOMATERIAL. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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.

    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 DEVICES - ORTHOPEDIC SALVAGE SYSTEM CPS TRANSVERSE PIN 32MM CATALOG #: 178527 LOT #: 280870, ORTHOPEDIC SALVAGE SYSTEM CPS ANCHOR PLUG 12MM CATALOG #: 178402 LOT #: 727330, ORTHOPEDIC SALVAGE SYSTEM CPS SPINDLE WITH PINS 600LBF CATALOG #: 178354 LOT #: 349010, ORTHOPEDIC SALVAGE SYSTEM CPS NUT CATALOG #: 178512 LOT #: 599470, ORTHOPEDIC SALVAGE SYSTEM RS POLY TIBIAL BEARING 16 CATALOG #: 161030 LOT #: 040940, ORTHOPEDIC SALVAGE SYSTEM RS NON-MODULAR PLATE LONG 71 CATALOG #: 161041 LOT #: 239710, ORTHOPEDIC SALVAGE SYSTEM RS POLY FEMORAL BUSHINGS CATALOG #: 161034 LOT #: 833940, ORTHOPEDIC SALVAGE SYSTEM POLY LOCKING PIN CATALOG #: 150478 LOT #: 716500, ORTHOPEDIC SALVAGE SYSTEM RS AXLE CATALOG #: 161035 LOT #: 859600, ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE CATALOG #: 150493 LOT #: 194890, ORTHOPEDIC SALVAGE SYSTEM POLY TIBIAL BUSHING CATALOG #: 150476 LOT #: 901590, SERIES A STANDARD 3 PEG PATELLA 31MM CATALOG #: 184764 LOT #: 013860. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS INSTABILITY AND BREAKAGE OF THE CUSTOM EXPANDABLE IMPLANT APPROXIMATELY SEVEN (7) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470315 REDUCED SIZE SCREW EXPANDABLE LEFT DISTAL FEMORAL 20CM REPLACEMENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 993290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE