BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT W/WR THN 28 1 PEG

    MDR report key: 13235368 · Received January 12, 2022

    Report

    Report Number
    0001825034-2021-03460
    Event Type
    Injury
    Date Received
    January 12, 2022
    Date of Event
    December 20, 2021
    Report Date
    June 1, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304436633
    PMA / PMN Number
    K040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD SSK 360 FEMUR R 67.5 T 67.5MM CATALOG # 185265 LOT # 6840257. VNGD SSK PS TIB BRG 16X63/67 X 16 CATALOG #: 185066 LOT #: 767190. VG 360 UNIV PST FM AUG 67.5X5 7.5X5MM CATALOG #: 185345 LOT #: 196360. BIOMET TIBIAL LOCKING BAR CATALOG #: 141205 LOT #: 304250. INTEGRAL REVISION 14X225MM RT CATALOG #: 166044 LOT #: A113. VG 360 DST FM AG 67.5X5 RL/LM MM RL/LM CATALOG #: 185305 LOT #: 101710. BMT SPLINED KNEE STM V2 14X120 120 CATALOG #: 148317 LOT #: 139980. ZIMMER ROUND GIGLI SAW BLADE CATALOG #: 2808-02 LOT #: 64982256. ZIMMER ROUND GIGLI SAW BLADE CATALOG #: 2808-02 LOT #: 64982256. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE REQUESTED BUT NOT RETURNED BY HOSPITAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2021-03459.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4 - IT IS UNKNOWN WHICH 1 OF THE 2 REPORTED DEVICES WAS REVISED DUE TO PAINFUL PATELLA AND FEMORAL LOOSENING. IT IS UNKNOWN WHICH EXACT DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: ITEM NAME: SERIES A PAT W/WR THN 28 1 PEG ITEM#: 184722, LOT#: 410380, MANUFACTURE DATE: SEP 3, 2014, STERILE EXPIRY DATE: AUG 31, 2019, UDI: N/A, 510K: K040770, PRO CODE: JWH. OR ITEM NAME: SERIES A PAT THN 28 3 PEG, ITEM#:184782, LOT#: 187960 , MANUFACTURE DATE: JUL 2, 2018, STERILE EXPIRY DATE: JUL 2, 2023, UDI: (B)(4). 510K: K040770, PRO CODE: JWH. D10 - MEDICAL PRODUCTS: VNGD SSK 360 FEMUR R 67.5 CATALOG # 185265 LOT # 6030464. SERIES A PAT THN 28 3 PEG CATALOG # 184782 LOT # 187960, BMT GB KNEE STM 12X40 CATALOG # 148142 LOT # 485110, BMT GB KNEE STM 14X40 CATALOG # 148144 LOT # 915370. VNGD SSK PSC TIB BRG 12X63/67 CATALOG # 183862 LOT # 427280, BMT 360 TIB TRAY 67MM CATALOG # 185202 LOT # 723760, BMT 360 TIB SM CRUCIATE WING CATALOG # 185650 LOT # 712250, THIN OSTEOTOME BLADE 8MM CATALOG # 430052 LOT # 471937, 1/8 QUICK REL DRL STERILE 2PK CATALOG # 32-486265 LOT # 813530, 1/8 QUICK REL DRL STERILE 2PK CATALOG # 32-486265 LOT # 813530. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2022-01320. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ADDITIONAL INFORMATION RECEIVED DOESN'T CHANGE THE PREVIOUS INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE THREE YEARS POST IMPLANTATION DUE TO PAINFUL PATELLA AND FEMORAL LOOSENING. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102036 SERIES A PAT W/WR THN 28 1 PEG PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 410380 00880304436633

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE