BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC 133 T1 PPS HO

    MDR report key: 9804906 · Received March 9, 2020

    Report

    Report Number
    0001825034-2020-01010
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 27, 2020
    Report Date
    June 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    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 CONFIRMED THE CORNER OF THE BLISTER CARTON TO BE CREASED. THE INSERTS ARE DAMAGED SUCH THAT WHITE PARTICLES ARE PRESENT WITHIN THE BLISTER CARTON. THE STERILE SEAL REMAINS INTACT. THE STERILITY OF THE DEVICE HAS NOT BEEN COMPROMISED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IT LIKELY TO BE DAMAGE DURING TRANSIT. THE DEVICE EVALUATION FOUND NO MALFUNCTION AND THE EVENT DID NOT CONTRIBUTE TO INJURY, THEREFORE THIS WOULD NOT BE CONSIDERED A REPORTABLE EVENT. 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 PRODUCTS : TPRLC XR MP T1 PPS 14X113MM CAT# 51-145140 LOT# 6156281, TPRLC 133 T1 PPS HO 17X154MM CAT# 51-104170 LOT# 6130017, FOREIGN COUNTRY: (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: 0001825034-2020-01009, 0001825034-2020-01011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STERILE PACKAGES WERE FOUND DAMAGED. NO PATIENTS WERE INVOLVED. 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
    268508 TAPERLOC 133 T1 PPS HO PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 6170627

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10.