BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSN FEM CR CMT CCR STD SZ 11 L

    MDR report key: 8292287 · Received January 31, 2019

    Report

    Report Number
    3007963827-2019-00014
    Event Type
    Injury
    Date Received
    January 31, 2019
    Report Date
    January 31, 2019
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    K113369
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORT: 0002648920-2019-00026. CONCOMITANT MEDICAL PRODUCTS: PSN ASF CR 16MM PLY L 9-12 J, ITEM# 42-5110-007-16, LOT# 62320334. PSN ALL POLY PAT PLY 41MM, ITEM# 42-5400-000-41, LOT# 63497946. PSN TIB STM 5 DEG SZ J L, ITEM# 42-5320-088-01, LOT# 63364168. PSN TPR ST 14 X +30 MM, ITEM# 42-5570-001-14, LOT# 63662913. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELEVANT DEVIATIONS/ ANOMALIES IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    IT WAS REPORTED THAT BILATERAL PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. PATIENT HAS BEEN EXPERIENCING PAIN, POPPING/CLICKING NOISES AND FEELING OF DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87863 PSN FEM CR CMT CCR STD SZ 11 L PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. NI 63590494

    Patients

    Seq Age Sex Outcome Treatment
    1 Other