BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT SM SIZE 4 PMA

    MDR report key: 11228390 · Received January 26, 2021

    Report

    Report Number
    3002806535-2021-00019
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    January 6, 2021
    Report Date
    February 19, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00017-2, 3002806535-2021-00018-2. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THESE ITEM NUMBERS. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: A RISK ASSESSMENT CANNOT BE CARRIED OUT AT THIS TIME, AS A REASON (HARM) FOR THE POLY EXCHANGE HAS NOT BEEN REPORTED. SINCE THE EVENT REPORTS REVISION SURGERY WAS UNDERTAKEN, THE OUTCOME OF THIS EVENT IN TERMS OF THE EXPECTED SEVERITY IS AS PER THE RMF AND CONSIDERED TO BE SEVERITY OF 3: MODERATE ¿ PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00017-1, 3002806535-2021-00018-1. ADDITIONAL INFORMATION RECEIVED: REASON FOR THE REVISION: POLY EXCHANGE. LOT NUMBERS OF THE INITIAL IMPLANT PRODUCTS RECEIVED: MEDICAL PRODUCT: OXF UNI TIB TRAY SZ B RM PMA, CATALOG #: 154721, LOT #: 998010; MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM SM PMA, CATALOG #: 161468, LOT #: 165060; MEDICAL PRODUCT: OXF ANAT BRG RT SM SIZE 4 PMA, CATALOG #: 159569, LOT #: 679680. INITIAL AND REVISION PROCEDURES PERFORMED AT THE SAME HOSPITAL AND BY SAME SURGEON. THE SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(4) 2019. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO POLY EXCHANGE WAS PERFORMED ON (B)(4) 2021.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO POLY EXCHANGE WAS PERFORMED ON (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF UNI TIB TRAY SZ B RM PMA, CATALOG #: 154721, LOT #: UNKNOWN. MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM SM PMA, CATALOG #: 161468, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00017, 3002806535-2021-00018. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO UNKNOWN REASON WAS PERFORMED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128170 OXF ANAT BRG RT SM SIZE 4 PMA KNEE ARTHROPLASTY NRA BIOMET UK LTD. N/A 679680

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEEH10