BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC+ REPLACEMENT RING SZ22

    MDR report key: 13181551 · Received January 6, 2022

    Report

    Report Number
    0001825034-2022-00062
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    December 13, 2021
    Report Date
    February 17, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MEH
    PMA / PMN Number
    K070369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) CUSTOMER HAS INDICATED THAT THE 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. CONCOMITANT MEDICAL PRODUCTS: PART # EP-108222 / E-POLY 32MM / LOT# 198270, PART # 650-1056/ BIOLOXD OPTION HD / LOT # 3033039, PART # 650-1066 / TPRSLEVE/ LOT # 3053198. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-00061.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THIS COMPONENT DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED AFTER EXPERIENCING ACUTE ONSET OF PAIN AND SQUEAKING. THE PAIN BECAME SO SEVERE OVER A WEEK THE PATIENT HAD TO USE CRUTCHES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THIS COMPONENT DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624335 RINGLOC+ REPLACEMENT RING SZ22 PROSTHESIS, HIP MEH ZIMMER BIOMET, INC. NI 295710

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10