BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 4799537 · Received May 27, 2015

    Report

    Report Number
    0001825034-2015-02246
    Event Type
    Injury
    Date Received
    May 27, 2015
    Report Date
    January 18, 2016
    Manufacturer
    BIOMET UK LTD
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY H PANDIT IN BONE JOINT SURG (BR} 2011;93-8:198¿204. IT IS LIKELY THAT THESE COMPLICATIONS AND REVISIONS HAVE ALREADY BEEN REPORTED; HOWEVER, IT CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION MADE AVAILABLE IN THE ARTICLE. SHOULD ADDITIONAL INFORMATION RELATING TO THE EVENTS BE RECEIVED, THE UPDATED INFORMATION WILL BE FORWARDED TO THE FDA.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4). PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "MINIMALLY INVASIVE OXFORD PHASE 3 UNICOMPARTMENTAL KNEE REPLACEMENT." THIS PROSPECTIVE STUDY DESCRIBES THE OUTCOME OF THE FIRST 1000 PHASE 3 OXFORD MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENTS IMPLANTED USING A MINIMALLY INVASIVE SURGICAL APPROACH FOR THE RECOMMENDED INDICATIONS BY TWO SURGEONS AND FOLLOWED UP INDEPENDENTLY. THE MEAN FOLLOW-UP WAS 5.6 YEARS (1 TO 11) WITH 547 KNEES HAVING A MINIMUM FOLLOW-UP OF FIVE YEARS. THE STUDY WAS CONDUCTED BETWEEN JUNE 1998 AND MARCH 2009, 97 KNEES RECEIVED A MEDIAL OXFORD UNICOMPARTMENTAL KNEE REPLACEMENT FOR INDICATIONS THAT ARE NOT RECOMMENDED. THESE 97 PATIENTS WERE NOT INCLUDED IN THE STUDY. DURING THE STUDY, 63 PATIENTS (72 KNEES) DIED. NO PATIENTS DIED AS A RESULT OF THEIR SURGERY, BUT OF UNRELATED CAUSES. THE JOURNAL ARTICLE REPORTS THAT 29 REVISION PROCEDURES OCCURRED DUE TO THE FOLLOWING REASONS: 6 REVISIONS DUE TO BEARING DISLOCATIONS, 3 REVISIONS DUE TO INFECTIONS, 6 REVISIONS DUE TO PAIN, 4 REVISIONS DUE TO PAIN AND SWELLING, 9 REVISIONS DUE TO LATERAL COMPARTMENT OSTEOARTHRITIS, 1 REVISIONS DUE TO LOOSE TIBIAL COMPONENT. THIS STUDY DEMONSTRATES THAT, WHEN USED FOR APPROPRIATE PATIENTS, MINIMALLY INVASIVE MOBILE-BEARING UNICOMPARTMENTAL KNEE REPLACEMENT IS SAFE AND EFFECTIVE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "MINIMALLY INVASIVE OXFORD PHASE 3 UNICOMPARTMENTAL KNEE REPLACEMENT." THIS PROSPECTIVE STUDY DESCRIBES THE OUTCOME OF THE FIRST 1000 PHASE 3 OXFORD MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENTS IMPLANTED USING A MINIMALLY INVASIVE SURGICAL APPROACH FOR THE RECOMMENDED INDICATIONS BY TWO SURGEONS AND FOLLOWED UP INDEPENDENTLY. THE MEAN FOLLOW-UP WAS 5.6 YEARS (1 TO 11) WITH 547 KNEES HAVING A MINIMUM FOLLOW-UP OF FIVE YEARS. THE STUDY WAS CONDUCTED BETWEEN JUNE 1998 AND MARCH 2009, 97 KNEES RECEIVED A MEDIAL OXFORD UNICOMPARTMENTAL KNEE REPLACEMENT FOR INDICATIONS THAT ARE NOT RECOMMENDED. THESE 97 PATIENTS WERE NOT INCLUDED IN THE STUDY. DURING THE STUDY, 63 PATIENTS (72 KNEES) DIED. NO PATIENTS DIED AS A RESULT OF THEIR SURGERY, BUT OF UNRELATED CAUSES. THE JOURNAL ARTICLE REPORTS THAT 29 REVISION PROCEDURES OCCURRED DUE TO THE FOLLOWING REASONS: 6 REVISIONS DUE TO BEARING DISLOCATIONS; 3 REVISIONS DUE TO INFECTIONS; 6 REVISIONS DUE TO PAIN; 4 REVISIONS DUE TO PAIN AND SWELLING; 9 REVISIONS DUE TO LATERAL COMPARTMENT OSTEOARTHRITIS; 1 REVISIONS DUE TO LOOSE TIBIAL COMPONENT. THIS STUDY DEMONSTRATES THAT, WHEN USED FOR APPROPRIATE PATIENTS, MINIMALLY INVASIVE MOBILE-BEARING UNICOMPARTMENTAL KNEE REPLACEMENT IS SAFE AND EFFECTIVE. ADDITIONAL INFORMATION RECEIVED BASED ON A REVIEW OF A FOLLOW UP JOURNAL ARTICLE ENTITLED, "THE CLINICAL OUTCOME OF MINIMALLY INVASIVE PHASE 3 OXFORD UNICOMPARTMENTAL KNEE ARTHROPLASTY." THE JOURNAL ARTICLE REPORTS A TOTAL OF 52 REVISION PROCEDURES OCCURRED DUE TO THE FOLLOWING REASONS: 7 REVISIONS DUE TO BEARING DISLOCATIONS; 5 REVISIONS DUE TO INFECTION; 7 REVISIONS DUE TO UNEXPLAINED PAIN; 1 REVISION DUE TO AVASCULAR NECROSIS OF LATERAL FEMORAL CONDYLE; 1 REVISION DUE TO TIBIAL MALPOSITION; 25 REVISIONS DUE TO LATERAL COMPARTMENT OSTEOARTHRITIS; 1 REVISION DUE TO INFECTION FOLLOWING ACL RECONSTRUCTION FOR TRAUMATIC RUPTURE; 1 REVISION DUE TO ASEPTIC LOOSENING OF FEMORAL COMPONENT; 1 REVISION DUE TO ASEPTIC LOOSENING OF TIBIAL COMPONENT; 1 REVISION DUE TO INSTABILITY; 1 REVISION DUE TO UNKNOWN; 1 REVISION DUE TO ACL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343748 UNKNOWN KNEE PROSTHESIS, KNEE NRA BIOMET UK LTD N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention