BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT 360 TIB AUG 67X5MM

    MDR report key: 8572864 · Received May 2, 2019

    Report

    Report Number
    0001825034-2019-01990
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    August 15, 2015
    Report Date
    January 3, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION FROM THE CUSTOMER. MEDICAL RECORDS WERE NOT PROVIDED AND PRODUCT WAS NOT RETURNED OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2019-01980; 0001825034-2019-01981; 0001825034-2019-01982; 0001825034-2019-01983; 0001825034-2019-01984; 0001825034-2019-01985; 0001825034-2019-01986; 0001825034-2019-01987; 0001825034-2019-01988; 0001825034-2019-01989; 0001825034-2019-01991; 0001825034-2019-01992; 0001825034-2019-01993. CONCOMITANT MEDICAL PRODUCTS: VNGD SSK 360 L FEM 65MM, ITEM# 185284, LOT# 3426503; VG 360 DST FM AG 65X10 RL/LM, ITEM# 185384, LOT# 144520; VG 360 DST FM AG 65X5 LL/RM, ITEM# 185324, LOT# 595300; VG 360 UNIV PST FM AUG 65X10, ITEM# 185424, LOT# 685550; SERIES A PAT THN 34 3 PEG, ITEM# 184786, LOT# 558320; BMT SPLINED KNEE STM V2 18X80, ITEM# 148308, LOT# 494710; BMT 360 TIB 5.0 OFFSET ADAPTER, ITEM# 185211, LOT# 950330; BMT 360 TIB TRAY 67MM, ITEM# 185202, LOT# 625860; BMT SPLINED KNEE STM V2 13X80, ITEM# 148303, LOT# 793180; BMT 360 TIB 5.0 OFFSET ADAPTER, ITEM# 185211, LOT# 853650; BMT 360 TIB AUG 67X5MM, ITEM# 185222, LOT# 354630; BMT 360 TIB SM CRUCIATE WING, ITEM# 185650, LOT# 570310; VNGD SSK PSC TIB BRG 14X63/67, ITEM# 183864, LOT# 388130. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION BECAUSE 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 IS REPORTED THE PATIENT HAD KNEE PAIN APPROXIMATELY FIVE (5) MONTHS POST REVISION SURGERY. PES BURSITIS AND WAS TREATED WITH VOLTAREN GEL AND PHYSICAL THERAPY. IT IS REPORTED THIS EVENT RESOLVED AFTER TREATMENT. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368931 BMT 360 TIB AUG 67X5MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 286600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other