BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT STD 31 3 PEG

    MDR report key: 8874022 · Received August 8, 2019

    Report

    Report Number
    0001825034-2019-03491
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    June 24, 2019
    Report Date
    December 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    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

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. PATIENT WAS EXPERIENCING STIFFNESS AND HAD RANGE OF MOTION OF 15-85 DEGREES. ON (B)(6) 2019 PATIENT HAD MANIPULATION UNDER ANESTHESIA PERFORMED DUE TO STIFFNESS/ANKYLOSIS OF THE LEFT KNEE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES 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

    PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AND LIMITED RANGE OF MOTION.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03489, 0001825034-2019-03489, AND 0001825034-2019-03490, AND 0001825034-2019-03491. CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR ILOK FEM-LT 65 CATALOG#: 183028 LOT#: J6499632, VGD CRUC RET TIB BRG 13X71/75 CATALOG#: 183443 LOT#: 281120, BIOMET CC I-BEAM TRAY 71MM CATALOG#: 141223 LOT#: J6493275. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. 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 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT AN I&D WITH POLY EXCHANGE FOR INFECTION 1 MONTH POST OPERATION. PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA A MONTH AFTER THE POLY SWAP DUE TO STIFFNESS AND LIMITED RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667872 SERIES A PAT STD 31 3 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 736080

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R