BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPLOOP BUTTON 10MM

    MDR report key: 10937427 · Received December 3, 2020

    Report

    Report Number
    0001825034-2020-04256
    Event Type
    Injury
    Date Received
    December 3, 2020
    Date of Event
    April 20, 2017
    Report Date
    April 27, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    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. D11 ITEM# 110017463; LOT# 714510; ZIPLOOP INLINE ITEM# 904755; LOT# 594120; #7 PE ZIPLOOP EXT TOGGLELOC 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: 0001825034-2021-00065.

    Description of Event or Problem · 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN: EVENT OCCURRED IN (B)(6). IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    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
    1403702 ZIPLOOP BUTTON 10MM SPORTSMED, IMPLANTS MBI ZIMMER BIOMET, INC. N/A 636410

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| R SEE H10 NARRATIVE