BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - XSMALL RIGHT SIZE 4

    MDR report key: 14629800 · Received June 8, 2022

    Report

    Report Number
    3002806535-2022-00252
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 6, 2022
    Report Date
    September 20, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279073023
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) CONCOMITANT MEDICAL DEVICES: OXF PH3 CEMENTLESS FEM SZ XSM; ITEM# 154912; LOT# 7055221, OXF UNI TIB TRAY SZ B RM PMA; ITEM# 154721; LOT# 7083494. REPORTV SOURCE FOREIGN: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2022-00249, 3002806535-2022-00251. 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. D10: MEDICAL DEVICES: OXF PH3 CEMENTLESS FEM SZ XSM; ITEM# 154912; LOT# 7055221. OXF UNI TIB TRAY SZ B RM PMA; ITEM# 154721; LOT# 7083494. OXF TRL BRG W/SLOTS XSM 4MM; ITEM# 32-422694; LOT# ZB130301. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H1, H2, H3, H6, H10. DIMENSIONAL ANALYSIS DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS OVERSIZE TO PRINT SPECIFICATIONS FOR DIMENSIONS A, B AND C. THIS IS AS EXPECTED BECAUSE THE BEARING HAS LIKELY BEEN AUTOCLAVED STERILISED AT THE HOSPITAL BEFORE RETURN AND ALSO HAS BEEN ADDITIONALLY SOAKED STERILISED FOR 5.5 HOURS UPON RETURN. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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 THAT DURING AN INITIAL KNEE ARTHROPLASTY THE BEARING SPUN OUT AND FELL OFF TO THE POSTERIOR JOINT CAPSULE SIDE. THE SURGEON THEN DECIDED TO USE A DIFFERENT SYSTEM, AND THE FEMUR AND TIBIA COMPONENTS WERE REMOVED. DURING REMOVAL, THE PATIENT¿S FEMUR BONE CRACKED. SURGERY WAS DELAYED FOR ABOUT 40 MINUTES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    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
    2438337 OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - XSMALL RIGHT SIZE 4 OXFORD PARTIAL KNEE SYSTEM NRA BIOMET UK LTD. N/A 7029590 05019279073023

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE| SEE H10 NARRATIVE.