BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER 20 DEGREE ELEVATED RIM 32MM FOR USE WITH 58MM SHELL

    MDR report key: 16271569 · Received January 31, 2023

    Report

    Report Number
    0001822565-2023-00172
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    October 8, 2018
    Report Date
    February 23, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K990135
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 00-2232-004-18 LOT# 63674177 CABLE READY GTR COCR CABLE. CAT#00-2232-004-18 LOT# 63716290 CABLE READY GTR COCR CABLE. CAT# 00-6202-058-22 LOT# 63365727 TM ACET SHELL 58MM CLUSTER. CAT# 00-7713-013-00 LOT# 63675172 M/L TPR KINECTIV STEM SZ 13.5. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920 - 2023 - 00007 0001822565 - 2023 - 00260 THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT NOTED THEY WERE REVISED APPROXIMATELY ONE (1) YEAR LATER DUE TO WORN POLY. MEDICAL RECORDS SHOW REVISION DUE TO PAIN AND HEMATOMA FROM AN UNKNOWN INJURY TO LEFT LEG. DURING THE REVISION, THE SURGEON NOTED METALLOSIS, SCARRING, AND LOCAL TISSUE REACTION. THE HEAD, NECK, AND LINER WERE EXCHANGED, THE CERCLAGE WIRES WERE REMOVED AND IRRIGATION AND DEBRIDEMENT TO HEMATOMA WITHOUT COMPLICATIONS. SUBSEQUENTLY AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED APPROXIMATELY SEVEN (7) MONTHS AFTER REVISION DUE TO RECURRENT HEMATOMA WITH THREE (3) PREVIOUS ASPIRATIONS WITH NEGATIVE CULTURES. THE LARGE HEMATOMA WAS EXCISED WITH DRAIN PLACED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105640 LINER 20 DEGREE ELEVATED RIM 32MM FOR USE WITH 58MM SHELL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 63624802

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE.