BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG LT MD SIZE 5 PMA

    MDR report key: 9897321 · Received March 30, 2020

    Report

    Report Number
    3002806535-2020-00192
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    July 30, 2019
    Report Date
    April 23, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279785957
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. TWO PRE-REVISION RADIOGRAPHS, THE SAME X-RAYS PROVIDED WITH (B)(4) (TAKEN ON AN UNKNOWN DATE), WERE PROVIDED FOR ANALYSIS WITH (B)(4): ONE ANTEROPOSTERIOR (AP) AND ONE MEDIOLATERAL (ML). ONE OF THE BEARING¿S BALL MARKERS IS VISIBLE IN THE AP X-RAY, WHEREAS THE WIRE AND A BALL MARKER ARE VISIBLE IN THE ML X-RAY, CONFIRMING THAT THE BEARING HAS DISLOCATED INTO THE ANTERIOR JOINT SPACE. THE FEMORAL AND TIBIAL COMPONENTS APPEAR ADEQUATELY SIZED AND POSITIONED, WITH THE POSSIBLE EXCEPTION OF THE TIBIAL TRAY BEING SHORT OF THE POSTERIOR EDGE OF THE TIBIAL PLATEAU. THE OXFORD PARTIAL KNEE SURGICAL TECHNIQUE STATES THAT THE TIBIAL TRAY SHOULD BE FLUSH WITH (OR HAVE LESS THAN 2 MM OVERHANG FROM) THE POSTERIOR EDGE OF THE TIBIAL PLATEAU. THE PATIENT IS MALE AND WAS (B)(6) AT THE TIME OF PRIMARY SURGERY. IN COMMUNICATIONS WITH THE COMPLAINTS TEAM, IT IS STATED THAT THERE WERE NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. THE 5 MM BEARING WAS REVISED WITH A THICKER (6 MM) BEARING, WHICH MAY SUGGEST JOINT LAXITY. THE CAUSE FOR REVISION CANNOT BE DETERMINED WITHOUT FURTHER INFORMATION SUCH AS PATIENT HEIGHT AND WEIGHT, ACTIVITY LEVEL, DATES WHEN THE PROVIDED RADIOGRAPHS WERE TAKEN, AS WELL AS POST-PRIMARY X-RAYS. THE MANUFACTURING HISTORY RECORDS (MHRS) FOR THE FEMORAL COMPONENT, TIBIAL TRAY AND ANATOMICAL BEARING HAVE BEEN CHECKED AND VERIFY THAT THE COMPONENTS WERE MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 4 SIMILAR COMPLAINTS FOUND FOR THE ITEM 159549. THERE WERE NO TRENDS IDENTIFIED FROM THE COMPLAINT HISTORY REVIEW. NO SAME LOT NUMBERS, NO SAME HOSPITALS AND THERE ARE NO TRENDS IN CAUSE. IN MOST CASES OF THE SIMILAR COMPLAINTS, CAUSE COULD NOT BE ESTABLISHED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6), 2018. SUBSEQUENTLY, A BEARING REVISION DUE TO DISLOCATION WAS PERFORMED ON (B)(6), 2019.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 D LM PMA, CATALOG #: 154724, LOT #: 342130 MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM MD PMA, CATALOG #: 161469, LOT #: 800730. 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 AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2018. SUBSEQUENTLY, A BEARING REVISION DUE TO DISLOCATION WAS PERFORMED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360861 OXF ANAT BRG LT MD SIZE 5 PMA UNICONDYLAR KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 561850 05019279785957

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R