BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT SM SIZE 6 PMA

    MDR report key: 18719353 · Received February 16, 2024

    Report

    Report Number
    3002806535-2024-00060
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    January 19, 2024
    Report Date
    December 20, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL DEVICES: OXF UNI TIB TRAY SZ B RM PMA; ITEM# 154721; LOT# 3141543. OXFORD UNI TWIN-PEG FEMORAL SM; ITEM# 166941; ITEM# 3221835. OPTIPAC 40 REFOBACIN BONE CEMENT R; ITEM# 4710500394; LOT# A3238E1308. G2 - FOREING: GERMANY. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED THE FOLLOWING. LEFT KNEE PERFORMED FIRST WITH NO DICTATION PROVIDED. RIGHT KNEE PERFORMED SECOND WITH DICTATION PROVIDED. ACL INTACT, NO RECOGNIZABLE HIGHER-GRADE CARTILAGE LESIONS IN THE LATERAL OR FEMOROPATELLAR COMPARTMENTS MEDIAL UKA PERFORMED WITHOUT COMPLICATIONS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED THE FOLLOWING. TWO VIEWS OF THE RIGHT KNEE LABELLED IMMEDIATE POSTOP DEMONSTRATES A MEDIAL COMPARTMENT HEMIARTHROPLASTY OF THE RIGHT KNEE WITH SURGICAL SKIN STAPLES. MEDIAL COMPARTMENT HEMIARTHROPLASTY WITH APPROPRIATE SIZE AND POSITION. TWO VIEWS OF THE RIGHT KNEE LABELLED PRE-REVISION DEMONSTRATES MEDIAL COMPARTMENT HEMIARTHROPLASTY WITH FRACTURED AND ANTERIORLY DISPLACED BEARING BETTER SEEN ON THE LATERAL FILM. TWO VIEWS OF THE RIGHT KNEE LABELLED POST REVISION DEMONSTRATE POSTSURGICAL CHANGES WITH SURGICAL SKIN STAPLES FROM A REVISED MEDIAL COMPARTMENT HEMIARTHROPLASTY WITH INTACT BEARING AGAIN SEEN. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, D4, D9, G3, G6, H2, H3, H4, H6, H11 PRODUCT WAS RETURNED AND VISUALLY EVALUATED WHICH IDENTIFIED SIGNS OF USE (PITS, GOUGES, MICROMOTION) AND CONFIRMING COMPLAINT OF BEARING FRACTURE. NOT ALL PIECES WERE RETURNED. THE ITEM WAS SENT FOR SEM WHICH CONCLUDED THAT THE FRACTURE OF THE BEARING WAS CAUSED BY OVERLOADING, POSSIBLY EXACERBATED BY MISALIGNMENT WITH THE TIBIAL TRAY RESULTING IN HIGH CRUSHING OR PINCHING FORCES ON THE POSTERIOR OF THE ARTICULAR SURFACE UNTIL FRACTURE. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD AN INITIAL BILATERAL KNEE MEDIAL UNICONDYLAR ARTHROPLASTY PERFORMED. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION OF THE RIGHT KNEE DUE TO FRACTURE OF THE BEARING. 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.

    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
    1484115 OXF ANAT BRG RT SM SIZE 6 PMA OXFORD HXLPE BEARINGS NRA BIOMET UK LTD. N/A 1859334

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization| R SEE H10 NARRATIVE.