BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ACETABULAR LINER

    MDR report key: 14305362 · Received May 6, 2022

    Report

    Report Number
    0001825034-2022-01145
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    February 13, 2022
    Report Date
    May 12, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PATIENT AGE RANGE WAS BETWEEN 37-90 YEARS OLD. IT WAS REPORTED THAT INITIAL REVISION SURGERY OCCURRED BETWEEN (B)(6) 2015 AND (B)(6) 2020. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ACETABULAR SHELL: CATALOG#NI, LOT#NI; UNKNOWN FEMORAL HEAD: CATALOG#NI, LOT#NI; UNKNOWN ORTHOPEDIC SALVAGE SYSTEM PROXIMAL FEMORAL COMPONENT: CATALOG#NI, LOT#NI; UNKNOWN ORTHOPEDIC SALVAGE SYSTEM BOLT AND CLAW: CATALOG#NI, LOT#NI; UNKNOWN ORTHOPEDIC SALVAGE SYSTEM DIAPHYSEAL SEGMENT: CATALOG#NI, LOT#NI; UNKNOWN ORTHOPEDIC SALVAGE SYSTEM AUGMENT: CATALOG#NI, LOT#NI; UNKNOWN ORTHOPEDIC SALVAGE SYSTEM FEMORAL STEM: CATALOG#NI, LOT#NI. LITERATURE: HECKMANN, N. D., NAKATA, H. L., CHUNG, B. C., BAKER, J. R., LONGJOHN, D. B., CHRIST, A. B., & OAKES, D. A. (2022). MODERN PROXIMAL FEMORAL REPLACEMENT IN REVISION TOTAL HIP ARTHROPLASTY FOR NONONCOLOGIC INDICATIONS. THE JOURNAL OF ARTHROPLASTY, S0883-5403(22)00208-X. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1016/J.ARTH.2022.02.057 MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0001825034-2022-01144. CUSTOMER HAS INDICATED THAT PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT UNDERWENT A PROXIMAL FEMORAL REPLACEMENT REVISION TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE AND EXPERIENCED A DISLOCATION AT THREE MONTHS POST-IMPLANTATION. SUBSEQUENTLY, THE PATIENT UNDERWENT AN OPEN REDUCTION WITH REVISION TO CONSTRAINED ACETABULAR COMPONENTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236083 UNKNOWN ACETABULAR LINER PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R SEE H10 NARRATIVE.