BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW

    MDR report key: 13497228 · Received February 9, 2022

    Report

    Report Number
    0001822565-2022-00381
    Event Type
    Injury
    Date Received
    February 9, 2022
    Report Date
    May 24, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024225039
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: NEXGEN STEMS EXTENSION SHARP FLUTED: CATALOG # 00598801514, LOT # 63203982; NEXGEN STEMS: CATALOG # 00598801117, LOT # 63215489; NEXGEN STEMMED TIBIAL COMPONENT: CATALOG # 00598800400, LOT # 63402724; LCCK NEXGEN FEMORAL COMPONENT: CATALOG # 00599401591, LOT # 63592705; FEMORAL AUGMENT BLOCK DISTAL ONLY PRECOAT: CATALOG # 00599003523, LOT # 61668091; FEMORAL AUGMENT BLOCK DISTAL ONLY PRECOAT: CATALOG # 00599003524, LOT # 77003571; LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW: CATALOG # 00599403217, LOT # 63864189. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0002648920-2022-00030, 0002648920-2022-00031, 0001822565-2022-00390, 0001822565-2022-00394, 0001822565-2022-00395. TWO DEVICE IDS WERE PROVIDED BY THE REPORTER; OF THESE, ONLY ONE (1) WAS REPORTED FOR PAIN, SWELLING, STIFFNESS AND DECREASE IN FLEXION. IT IS UNKNOWN WHICH EXACT DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW: CATALOG # 00599403212, LOT # 62749599, MANUFACTURE DATE: JUL 23, 2014, STERILE EXPIRY DATE: JUL 31, 2022, UDI: (B)(4), 510K: K173057, PRO CODE: JWH, OR LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW: CATALOG # 00599403217, LOT # 63864189, MANUFACTURE DATE: DEC 13, 2017, STERILE EXPIRY DATE: DEC 31, 2025, UDI: (B)(4), 510K: K173057, PRO CODE: JWH.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MEDICAL RECORDS REVIEW INDICATES THE RANGE OF MOTION HAS DECREASED AND THERE IS WELLING AND STIFFNESS WITH PAIN REPORTED. 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

    IT WAS REPORTED PATIENT IS EXPERIENCING PAIN OVER THE PES ANSERINE BURSA, SWELLING, STIFFNESS AND DECREASE IN FLEXION TWO YEARS POST IMPLANTATION. LABS AND A BONE SCAN WERE ORDERED, BUT NO FURTHER INFORMATION OR REPORT OF INTERVENTION HAS BEEN PROVIDED AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    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
    541651 LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 62749599 00889024225039

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other