BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD FEMORAL COMPONENT

    MDR report key: 10178109 · Received June 22, 2020

    Report

    Report Number
    3002806535-2020-00289
    Event Type
    Injury
    Date Received
    June 22, 2020
    Date of Event
    December 24, 2019
    Report Date
    July 22, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN SINGAPORE. D11: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00288-1, 3002806535-2020-00290-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. SIX RADIOGRAPHS WERE PROVIDED WITH (B)(4). ON THE IMMEDIATE POST-SURGERY ANTEROPOSTERIOR RADIOGRAPH, THE FEMORAL COMPONENT APPEARS TO BE ROTATED AND NOT ALIGNED WITH THE TIBIAL TRAY. ON THE IMMEDIATE POST-SURGERY MEDIOLATERAL RADIOGRAPH, THE TIBIAL TRAY MAY BE OVERHANGING POSTERIORLY, ALTHOUGH THIS CANNOT BE CONFIRMED DUE TO THE QUALITY OF THE PROVIDED RADIOGRAPH. THE OXFORD PARTIAL KNEE SURGICAL TECHNIQUE RECOMMENDS THE TIBIAL TRAY TO BE FLUSH WITH OR TO HAVE LESS THAN 2 MM OVERHANG FROM THE POSTERIOR EDGE OF THE TIBIAL PLATEAU. SOME DEBRIS APPEARS TO BE VISIBLE WITHIN THE POSTERIOR JOINT SPACE. ON THE ANTEROPOSTERIOR RADIOGRAPH TAKEN 3 MONTHS AFTER SURGERY, THE TIBIAL TRAY APPEARS SUBSIDED. THE ANATOMY OF THE PATIENT TIBIA BELOW THE TIBIAL TRAY SUGGESTS THAT A BONE FRACTURE HAS OCCURRED. THE PATIENT FEMUR APPEARS ROTATED INTO VARUS, WITH BONE-ON-BONE CONTACT BETWEEN THE FEMUR AND THE INTERCONDYLAR REGION OF THE TIBIA, AND WITH THE FEMORAL COMPONENT POSSIBLY CONTACTING THE MEDIAL INTERCONDYLAR TUBERCLE. THE TIBIAL TRAY SUBSIDENCE, THE VARUS ALIGNMENT OF THE JOINT AND THE TIBIAL FRACTURE ARE STILL VISIBLE IN THE TWO RADIOGRAPHS TAKEN IN MAY 2020. THE OBSERVED TIBIAL TRAY SUBSIDENCE AND TIBIAL FRACTURE EXPLAIN THE PAIN AND INSTABILITY REPORTED BY THE PATIENT. NO PATIENT INFORMATION SUCH AS AGE, HEIGHT, WEIGHT, BMI, ACTIVITY LEVEL, BONE STOCK QUALITY AND PRE-EXISTING CONDITIONS WAS PROVIDED AT THE TIME OF WRITING THIS ASSESSMENT. IT IS UNKNOWN WHETHER ANY EVENT SUCH AS A FALL OR TRAUMA OCCURRED THAT COULD HAVE CONTRIBUTED TO THE OBSERVED TIBIAL TRAY SUBSIDENCE AND TIBIAL FRACTURE. SUB-OPTIMAL SIZING AND ALIGNMENT OF COMPONENTS MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE EARLY FAILURE OF THE DEVICE; IT HAS ALSO BEEN REPORTED THAT SUB-OPTIMAL TIBIAL PLATEAU PREPARATION MAY LEAD TO TIBIAL FRACTURE AND TIBIAL TRAY SUBSIDENCE IN OXFORD CEMENTLESS SYSTEMS. HOWEVER, THIS CANNOT BE CONFIRMED WITHOUT BETTER QUALITY RADIOGRAPHS, PATIENT INFORMATION AND SURGICAL NOTES BEING PROVIDED AND WITHOUT EXAMINATION OF ALL COMPONENTS ONCE REVISED. NO DETAILS OF THE IMPLANTED COMPONENTS HAVE BEEN MADE AVAILABLE AT THE TIME OF WRITING THIS ASSESSMENT, THEREFORE THE MANUFACTURING HISTORY RECORDS COULD NOT BE CHECKED. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. THE ITEM NUMBER AND LOT NUMBER IDENTIFICATION NECESSARY TO REVIEW THE COMPLAINT HISTORY WAS NOT PROVIDED. 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. CORRECTIVE ACTION TAKEN: NO CORRECTIVE ACTION REQUIRED AT THIS TIME. PREVENTIVE ACTION TAKEN: NO PREVENTIVE ACTION REQUIRED AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. H3 OTHER TEXT : INVESTIGATION IS BASED ON RADIOGRAPHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN (B)(6) 2019. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN AND INSTABILITY WHILE WALKING. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REVISION DATE; HOWEVER, NO FURTHER INFORMATION AVAILABLE. THERE ARE 3 COMPONENT OF OXFORD IMPLANTS FOR THE SURGERY. THESE IMPLANTS ARE STILL IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: UNKNOWN OXFORD TIBIAL COMPONENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MEDICAL PRODUCT: UNKNOWN OXFORD BEARING, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00288, 3002806535-2020-00290. (B)(6). 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 KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN (B)(6) 2019. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN AND INSTABILITY WHILE WALKING. AWAITING A DATE FOR REVISION SURGERY. THERE ARE 3 COMPONENT OF OXFORD IMPLANTS FOR THE SURGERY. THESE IMPLANTS ARE STILL IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645392 UNKNOWN OXFORD FEMORAL COMPONENT UNKNOWN KNEE ARTHROPLASTY JWH BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other