BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT THN 34 3 PEG

    MDR report key: 8572843 · Received May 2, 2019

    Report

    Report Number
    0001825034-2019-01984
    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
    K040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE AS THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE AS THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    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, 0001825034-2019-01985, 0001825034-2019-01986, 0001825034-2019-01987, 0001825034-2019-01988, 0001825034-2019-01989, 0001825034-2019-01990, 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. 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# 286600. 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
    368687 SERIES A PAT THN 34 3 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 558320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other