BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 PPS HO 18.0

    MDR report key: 7764673 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-07262
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    January 7, 2016
    Report Date
    September 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK110400
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. AFTER REVIEW OF OP NOTES AND CT SCAN, WHICH STATED THE HIP ARTHROPLASTY APPEARED IN APPROPRIATE POSITION, THE LIKELY CAUSE OF THE PERIPROSTHETIC FRACTURE WAS THE PATIENT FALL. THE REASON FOR THE FALL IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. ITEM NUMBER: (B)(4), ITEM NAME: BIOLOX DELTA HEAD, LOT #: 811690; ITEM NUMBER: (B)(4), ITEM NAME: BIOLOX DELTA TAPER ADAPTOR, LOT #: 638920; ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN LINER, LOT #: UNKNOWN; ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN SHELL, LOT #: UNKNOWN. 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 PATIENT WAS REVISED WITH OPEN REDUCTION AND INTERNAL FIXATION ON APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO STEM SUBSIDENCE AND PERIPROSTHETIC FRACTURE AFTER EXPERIENCING A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604367 TPRLC 133 MP TYPE1 PPS HO 18.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3684094

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R