BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, HIP

    MDR report key: 12797159 · Received November 11, 2021

    Report

    Report Number
    0001825034-2021-03116
    Event Type
    Injury
    Date Received
    November 11, 2021
    Report Date
    November 17, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IMPLANT DATE: LEFT: (B)(6) 2008 - RIGHT: (B)(6) 2008. CONCOMITANT PRODUCTS: X180311-BI-METRIC/X POR NC 11X135-362280; X180310-BI-METRIC/X POR NC 10X130-463480; 11-163690-32MM M2A HI CARBON HD +6MM NK-985990; 11-163688-32MM M2A HI CARBON HD STD NK-544260; 10-111152-C2A-T M/H RAD 2HL SHL 41/52MM-949700; 10-111152-C2A-T M/H RAD 2HL SHL 41/52MM-919670. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 10193, 0001825034 - 2018 - 10191, 0001825034 - 2018 - 10192. TWO DEVICE IDS WERE PROVIDED BY THE CUSTOMER/REPORTER; OF THESE, ONLY ONE WAS REVISED. IT IS UNKNOWN WHICH EXACT SIDE/DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: LEFT SIDE: ITEM#: 15-105044, LOT#: 473940, MANUFACTURE DATE: OCT 1, 2007, STERILE EXPIRY DATE: OCT 31, 2017, 510K: K003363, PRO CODE: KWY, IMPLANT DATE: (B)(6) 2008. OR RIGHT SIDE: ITEM#: 15-105044, LOT#: 090660, MANUFACTURE DATE: DEC 1, 2007, STERILE EXPIRY DATE: DEC 31, 2017, 510K: K003363, PRO CODE: KWY, IMPLANT DATE: (B)(6) 2008. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: LEFT SIDE C2A SHELL UPDATED: MANUFACTURING DATE: SEP 30, 2007. EXPIRATION DATE: SEP 30, 2017. D10: RIGHT SIDE C2A SHELL CORRECTED: LOT 949670 UPDATED: MANUFACTURING DATE: SEP 30, 2007. EXPIRATION DATE: SEP 30, 2017. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE INITIAL OP RECORDS INDICATED NO COMPLICATIONS. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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 UNDERWENT A HIP REVISION DUE TO UNKNOWN REASONS AT AN UNKNOWN AMOUNT OF TIME POST INITIAL IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690529 PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R