BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    OXF UNI TIB TRAY SZ B RM PMA

    MDR report key: 11568155 · Received March 25, 2021

    Report

    Report Number
    3002806535-2021-00090
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    March 8, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P01004
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION FOLLOWING RECEIPT OF THE PRODUCT NUMBERS. MEDICAL PRODUCT: OXF ANAT BRG RT SM SIZE 5 PMA, CATALOG #: 159570, LOT #: 274780. MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM SM PMA, CATALOG #: 161468, LOT #: 582560. MEDICAL PRODUCT: OXF RESEC CMNTD 3PK STRYK 6, CATALOG #: 506269, LOT #: P424336. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00089-2, 3002806535-2021-00091-2. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 4 COMPLAINTS REPORTED WITH THE ITEM 159570, 5 COMPLAINTS REPORTED WITH THE ITEM 154721 AND 6 COMPLAINTS REPORTED WITH THE ITEM 161468 (INCLUDING INITIATING COMPLAINT). WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    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: 3002806535-2021-00089-1, 3002806535-2021-00091-1. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS COULD NOT BE PERFORMED AS ITEM NUMBERS AND LOT NUMBERS ARE UNKNOWN. A REVIEW OF THE COMPLAINT DATABASE COULD NOT BE PERFORMED AS ITEM NUMBERS AND LOT NUMBERS ARE UNKNOWN. RISK ASSESSMENT: WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT AND WITHOUT ADEQUATE INFORMATION RECEIVED REGARDING THE EVENT, ROOT CAUSE COULD NOT BE DETERMINED AND THEREFORE RISK COULD NOT BE ASSESSED AGAINST OCCURRENCE OR ANY NEW PREVIOUSLY UNIDENTIFIED RISK. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CONCOMITANT MEDICAL DEVICES: MEDICAL PRODUCT: UNKNOWN OXFORD BEARING COMPONENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN; MEDICAL PRODUCT: UNKNOWN OXFORD FEMORAL COMPONENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00089, 3002806535-2021-00091. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465490 OXF UNI TIB TRAY SZ B RM PMA OXFORD PARTIAL KNEE SYSTEM NRA BIOMET UK LTD. N/A 177680

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R SEE H10 NARRATIVE| SEEH10