BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMANCE TOTAL KNEE PROSTHESIS

    MDR report key: 9238057 · Received October 25, 2019

    Report

    Report Number
    0009610576-2019-00015
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    May 9, 2019
    Report Date
    December 16, 2019
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    HRY
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ATTACHED (B)(4) PRODUCT ANALYSIS REPORT. D11: MEDICAL PRODUCT. TIBIAL TRAY REF 141233; LOT 311360. INLAY REF. 179370; LOT 482710. G3: EVENT OCURRED IN GERMANY. G5:THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K023546.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD A RTKA IN (B)(6) 2007. IN (B)(6) 2018, AN ASK (ARTHROSCOPY) OF THE KNEE WAS DIAGNOSED WITH A LOW GRADE INFECTION. IN THE FURTHER COURSE A PUNCTURE AND AN ASK OF THE KNEE JOINT WERE CARRIED OUT WITHOUT PROOF OF INFECTION BUT WITH CLEAR INDICATIONS OF AN INLAY ABRASION AS WELL AS INLAY ABORT. AFTER APPROPRIATE PREOPERATIVE PREPARATION ON (B)(6) 2019, THE KNEE WAS REVISED WITHOUT COMPLICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: TIBIAL TRAY REF 141233; LOT 311360. INLAY REF. 179370; LOT 482710. REPORT SOURCE: EVENT OCCURRED IN (B)(6). PMA/510K:THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K023546. PRODUCT NOT RETURNED YET.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAD A RTKA IN (B)(6) 2007. IN (B)(6) 2018, AN ASK (ARTHROSCOPY) OF THE KNEE WAS DIAGNOSED WITH A LOW GRADE INFECTION. IN THE FURTHER COURSE A PUNCTURE AND AN ASK OF THE KNEE JOINT WERE CARRIED OUT WITHOUT PROOF OF INFECTION BUT WITH CLEAR INDICATIONS OF AN INLAY ABRASION AS WELL AS INLAY ABORT. AFTER APPROPRIATE PREOPERATIVE PREPARATION ON (B)(6) 2019, THE KNEE WAS REVISED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036217 PERFORMANCE TOTAL KNEE PROSTHESIS PROSTHESIS, KNEE HRY BIOMET SPAIN, S.L. N/A 2006080511

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R