BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 FP TYPE1 PPS HO 5.0

    MDR report key: 7556138 · Received May 31, 2018

    Report

    Report Number
    0001825034-2018-03589
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    May 2, 2018
    Report Date
    December 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK103755
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE CAVITIES CONFIRMED THEY HAVE BEEN DENTED DUE TO IMPLANT MOVEMENT WITHIN THE PACKAGE. INSPECTION OF THE CAVITIES SHOWS THE SEALS WERE NOT COMPROMISED AND IMPLANTS DID NOT PUNCTURE THE CAVITIES. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: 51-101050, TPRLC 133 FP TYPE1 PPS HO 5.0, 6170379; 51-101050, TPRLC 133 FP TYPE1 PPS HO 5.0, 6170379. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03588, 0001825034 - 2018 - 03590.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STERILE PACKAGE HAD A PROTRUSION DUE TO IMPACT OF THE STEM DURING DISTRIBUTION, AND IT WILL LIKELY BREAK STERILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400247 TPRLC 133 FP TYPE1 PPS HO 5.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6170379

    Patients

    Seq Age Sex Outcome Treatment
    1