BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPLOOP INLINE

    MDR report key: 11154555 · Received January 12, 2021

    Report

    Report Number
    0001825034-2021-00065
    Event Type
    Injury
    Date Received
    January 12, 2021
    Date of Event
    May 31, 2017
    Report Date
    April 27, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS REPORTED AS A RE-RUPTURE FROM A SPORTS INJURY, NEARLY 3 YEAR POST-OPERATIVELY. THERE ARE NO DEVICE MALFUNCTION ALLEGATIONS, AS THE AUTOGRAFT ITSELF TORE AND DID NOT INVOLVE A DEVICE FAILURE. UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NAC. THIS EVENT WAS REPORTED AS A RE-RUPTURE FROM A SPORTS INJURY, NEARLY 3 YEAR POST-OPERATIVELY. THERE ARE NO DEVICE MALFUNCTION ALLEGATIONS, AS THE AUTOGRAFT ITSELF TORE AND DID NOT INVOLVE A DEVICE FAILURE.

    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: ITEM# 110010873; LOT# 636410; ZIPLOOP BUTTON 10MM. ITEM# 904755; LOT# 594120; #7 PE ZIPLOOP EXT TOGGLELOC. REPORT SOURCE - FOREIGN: EVENT OCCURRED IN (B)(6). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. 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: 0001825034-2020-04256. DEVICE EVALUATED BY MANUFACTURER? DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO RE-RUPTURE OF THE KNEE ACL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51132 ZIPLOOP INLINE SPORTSMED, IMPLANTS HWC ZIMMER BIOMET, INC. N/A 714540

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| R