BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PH3 CEMENTLESS FEM SZ M

    MDR report key: 18920187 · Received March 18, 2024

    Report

    Report Number
    3002806535-2024-00092
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    February 22, 2024
    Report Date
    June 10, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    00887868353772
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D-10 OXF UNI CMNTLS TIB SZ C RM, ITEM# 166575, LOT# 7246480. OXF ANAT BRG RT MD SIZE 6 PMA, ITEM# 159578, LOT# 7052368. G2 ¿ FOREIGN ¿ NETHERLANDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2024 - 00093, 3002806535 - 2024 - 00094. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE ITEM REF. 166575, NO ADDITIONAL RELATED COMPLAINTS FOR ITEMS REF. 154926 AND 159578, AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW OF THE INITIAL NOTES IDENTIFIED AN UNCEMENTED INITIAL MEDIAL KNEE HEMIARTHROPLASTY WITHOUT COMPLICATIONS. REVIEW OF THE REVISION NOTES IDENTIFIED A REVISION DUE TO MALALIGNMENT AND PERSISTENT PAIN, WITHOUT COMPLICATION. NO CONTRIBUTING FACTORS TO THE EVENT WERE FOUND. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW OF THE IMMEDIATE POST-OP IMAGES DEMONSTRATES ANATOMIC ALIGNMENT OF A MEDIAL UNICOMPARTMENTAL ARTHROPLASTY WITHOUT ABNORMALITY. AN INTERVAL CHANGE IN POSITION OF THE TIBIAL IMPLANT WHICH APPEARS SLIGHTLY ROTATED AND SUBSIDED WAS IDENTIFIED. A LATERAL VIEW WOULD BE OF VALUE FOR BETTER CHARACTERIZATION OF THE IMPLANT POSITION. THERE IS NO FRACTURE. FINALLY, A REVIEW OF THE X-RAY IN THE STANDING POSITION, REVEALED THE TIBIAL IMPLANT APPEARING AGAIN MALPOSITIONED BUT UNCHANGED. THERE IS PELVIC OBLIQUITY HIGHER ON THE LEFT. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 FROM A CLINICAL STUDY THAT A PATIENT HAD AN INITIAL RIGHT MEDIAL KNEE UNICONDYLAR ARTHROPLASTY APPROXIMATELY ONE YEAR AGO. A MONTH AGO THE PATIENT WAS CONVERTED TO A TOTAL KNEE ARTHROPLASTY DUE TO PERSISTENT PAIN AND MALALIGNMENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    1017877 OXFORD PH3 CEMENTLESS FEM SZ M PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL NRA BIOMET UK LTD. N/A 7349086 00887868353772

    Patients

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