BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC 133 MP TYPE1 PPS SO 15.0 1

    MDR report key: 9915758 · Received April 2, 2020

    Report

    Report Number
    0001825034-2020-01363
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 17, 2020
    Report Date
    July 20, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K110400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D11: TPRLC 133 MP TYPE1 PPS SO 16.0 1 CAT#51-106160 LOT#R3129377A. SIX BOXES WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION ALL SIX BOXES HAVE LOOSE WHITE DEBRIS AND ONE PACKAGE (2931358) HAS VISIBLE BLACK DEBRIS. THE STERILE BARRIER IS INTACT ON ALL SIX PACKAGES. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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 CAUSING THE FOAM PACKAGING TO BECOME ABRADED AND SHED. 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

    THE DEVICE EVALUATION FOUND STERILITY WAS NOT COMPROMISED AND THE EVENT DID NOT CONTRIBUTE TO INJURY, THEREFORE THIS WOULD NOT BE CONSIDERED A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TPRLC 133 MP TYPE1 PPS SO 16.0 1 CAT# 51-106160 LOT# 3129377, TPRLC XR T1 PPS 17X154MM MM T1 CAT# 51-105170 LOT# 2931358, TPRLC 133 MP TYPE1 PPS SO 15.0 1 CAT# 51-106150 LOT# 3387021, TPRLC XR MP FP T1 PPS 7X99MM T1 CAT# 51-149070 LOT# 3242952, TPRLC 133 MP TYPE1 PPS SO 16.0 1 CAT# 51-106160 LOT# 3674145. (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: 0001825034-2020-01362, 0001825034-2020-01364, 0001825034-2020-01365, 0001825034-2020-01366, 0001825034-2020-01367.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEBRIS WAS IDENTIFIED WITHIN STERILE PACKAGES. THERE WAS NO PATIENT INVOLVEMENT. 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
    380069 TAPERLOC 133 MP TYPE1 PPS SO 15.0 1 PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. NI 3249563

    Patients

    Seq Age Sex Outcome Treatment
    1