BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD FEMORAL COMPONENT

    MDR report key: 9811818 · Received March 10, 2020

    Report

    Report Number
    3002806535-2020-00132
    Event Type
    Injury
    Date Received
    March 10, 2020
    Date of Event
    February 13, 2020
    Report Date
    April 20, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10, G4, H1, H2, H3, H6, H10. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00130-1, 3002806535-2020-00131-1, AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. ONE ANTEROPOSTERIOR (AP), A PRE-REVISION RADIOGRAPH WAS PROVIDED WITH (B)(4) FOR REVIEW. THE DATE ON WHICH THE RADIOGRAPH WAS TAKEN HAS NOT BEEN PROVIDED. IMMEDIATE POST-PRIMARY SURGERY RADIOGRAPHS ARE REQUIRED TO ASSESS THE INITIAL FIT, SIZING AND POSITIONING OF COMPONENTS. THE ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (ZPER) PROVIDED WITH THE COMPLAINT STATES THAT THE EVENT OCCURRED ON (B)(6) 2020 AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. MOREOVER, THE ZPER STATES OXFORD KNEE DONE 5 YEARS AGO REVISED FOR FEMORAL MISPLACEMENT AND PAIN TO TKR. PATIENT DETAILS SUCH AS AGE, WEIGHT, HEIGHT, AND ANY CONDITION(S) CONTRIBUTING TO THE REVISION HAVE NOT BEEN PROVIDED. THE ORIENTATION OF THE KNEE IN THE PROVIDED RADIOGRAPH DOES NOT ALLOW FOR THE FULL ASSESSMENT OF THE FIT, SIZING AND POSITIONING OF COMPONENTS. THE OXFORD SURGICAL TECHNIQUE [1] RECOMMENDS THAT THE PATIENT LIES SUPINE ON THE X-RAY TABLE AND THE LEG AND X-RAY BEAM ARE MANIPULATED UNDER FLUOROSCOPIC CONTROL UNTIL THE TIBIAL COMPONENT APPEARS EXACTLY END-ON IN SILHOUETTE. IN THIS PROJECTION, THE ALIGNMENT OF THE BEAM WITH THE FLAT ORTHOGONAL SURFACES (HORIZONTAL TRAY AND VERTICAL LATERAL WALL AND KEEL) ALLOWS GREAT ACCURACY AND REPRODUCIBILITY. THE X-RAY MARKERS (WIRE AND BALLS) OF THE POLYETHYLENE BEARING INDICATE THAT THE COMPONENT MAY BE OVERHANGING SLIGHTLY IN THE MEDIAL JOINT SPACE; HOWEVER, THIS CANNOT BE CONFIRMED DUE TO THE ABOVE-MENTIONED REASON. THE COMPLAINT DESCRIPTION STATES THAT REVISION WAS CARRIED OUT DUE TO FEMORAL MISPLACEMENT. THE OXFORD OXFORD SURGICAL TECHNIQUE [1] RECOMMENDS THE FEMORAL COMPONENT TO BE CENTRAL WITH RESPECT TO THE FEMORAL CONDYLE AND ORIENTED WITHIN 10 DEGREES OF EITHER VARUS OR VALGUS ANGLE. HOWEVER, THIS ALSO CANNOT BE ASSESSED DUE TO THE ABOVE-MENTIONED REASON. PART AND LOT NUMBERS OF COMPONENTS WERE NOT PROVIDED, THEREFORE THE MANUFACTURING HISTORY RECORDS (MHRS) COULD NOT BE RETRIEVED AND CHECKED. WITHOUT THE OPPORTUNITY TO EXAMINE THE REVISED COMPONENTS AND WITHOUT PROVISION OF FURTHER RADIOGRAPHIC, SURGICAL AND PATIENT INFORMATION, THE ROOT CAUSE OF THE REPORTED PAIN COULD NOT BE DETERMINED AND THE REPORTED FEMORAL MISPLACEMENT COULD NOT BE CONFIRMED IN THIS INSTANCE. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. H3 OTHER TEXT : PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO PAIN AND FEMORAL MISPLACEMENT WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED. :CONCOMITANT MEDICAL PRODUCTS MEDICAL PRODUCT: UNKNOWN TIBIAL COMPONENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN MEDICAL PRODUCT: UNKNOWN BEARING, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00131, 3002806535-2020-00130. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO PAIN AND FEMORAL MISPLACEMENT WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274898 UNKNOWN OXFORD FEMORAL COMPONENT KNEE PROTHESIS JWH BIOMET UK LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R