BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 2318199 · Received November 1, 2011

    Report

    Report Number
    0001825034-2011-00964
    Event Type
    Injury
    Date Received
    November 1, 2011
    Date of Event
    October 7, 2011
    Report Date
    October 16, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KXA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENTS. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THESE TYPES OF EVENTS CAN OCCUR. LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY. FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT. EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION. DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS. THE RECAP FEMORAL AND ACETABULAR COMPONENTS ARE MANUFACTURED AND SUPPLIED BY TWO BIOMET FACILITIES, THE SECOND IS OUTSIDE OF THE US.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.THE FOLLOWING IS A LIST OF PART NUMBERS MANUFACTURED BY BIOMET US AND SOLD TO BIOMET (B)(4). ONE OR MORE OF FOLLOWING MAY BE INVOLVED IN THE EVENT(S): BRAND NAME RECAP CEMENT FMRL HD RESUR42MM; CATALOG NUMBER 157242; 510(K) NUMBER K021799. BRAND NAME RECAP CEMENT FMRL HD RESUR44MM; CATALOG NUMBER 157244; 510(K) NUMBER K021799. BRAND NAME RECAP CEMENT FMRL HD RESUR46MM; CATALOG NUMBER 157246; 510(K) NUMBER K021799. BRAND NAME RECAP CEMENT FMRL HD RESUR48MM; CATALOG NUMBER 157248; 510(K) NUMBER K021799. BRAND NAME RECAP CEMENT FMRL HD RESUR50MM; CATALOG NUMBER 157250; 510(K) NUMBER K021799. BRAND NAME RECAP CEMENT FMRL HD RESUR52MM; CATALOG NUMBER 157252; 510(K) NUMBER K021799. BRAND NAME RECAP CEMENT FMRL HD RESUR54MM; CATALOG NUMBER 157254; 510(K) NUMBER K021799. BRAND NAME RECAP CEMENT FMRL HD RESUR56MM; CATALOG NUMBER 157256; 510(K) NUMBER K021799. BRAND NAME RECAP PF FMRL HD RESURF 38MM; CATALOG NUMBER US157138; 510(K) NUMBER K023188. BRAND NAME RECAP PF FMRL HD RESURF 40MM; CATALOG NUMBER US157140; 510(K) NUMBER K023188. BRAND NAME RECAP PF FMRL HD RESURF 42MM; CATALOG NUMBER US157142; 510(K) NUMBER K023188. BRAND NAME RECAP PF FMRL HD RESURF 44MM; CATALOG NUMBER US157144; 510(K) NUMBER K023188. BRAND NAME RECAP PF FMRL HD RESURF 46MM; CATALOG NUMBER US157146; 510(K) NUMBER K023188. BRAND NAME RECAP PF FMRL HD RESURF 48MM; CATALOG NUMBER US157148; 510(K) NUMBER K023188. BRAND NAME RECAP PF FMRL HD RESURF 50MM; CATALOG NUMBER US157150; 510(K) NUMBER K023188. BRAND NAME RECAP PF FMRL HD RESURF 52MM; CATALOG NUMBER US157152; 510(K) NUMBER K023188. BRAND NAME RECAP PF FMRL HD RESURF 54MM; CATALOG NUMBER US157154; 510(K) NUMBER K023188. BRAND NAME RECAP PF FMRL HD RESURF 56MM; CATALOG NUMBER US157156; 510(K) NUMBER K023188. BRAND NAME RECAP PF FMRL HD RESURF 58MM; CATALOG NUMBER US157158; 510(K) NUMBER K023188. BRAND NAME RECAP PF FMRL HD RESURF 60MM; CATALOG NUMBER US157160; 510(K) NUMBER K023188.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDED ¿MALFUNCTION.¿ IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    ANNUAL REPORT (2011) OF THE NATIONAL JOINT REPLACEMENT REGISTRY OF THE AUSTRALIAN ORTHOPAEDIC ASSOCIATION REPORTED A TOTAL OF THIRTEEN (13) REVISION PROCEDURES WERE PERFORMED BETWEEN 2004 AND 2010 TO REMOVE RECAP FEMORAL AND ACETABULAR COMPONENTS DUE TO LOOSENING/LYSIS, FRACTURE, INFECTION, PAIN & DISLOCATION. REPORT DID NOT CONTAIN SPECIFIC INFORMATION THAT WOULD CONFIRM WHETHER THE INFORMATION WAS PREVIOUSLY PROVIDED TO BIOMET. ADDITIONAL INFORMATION RECEIVED FROM THE (B)(4) INDICATES A TOTAL OF 22 PATIENTS WERE REVISED.

    Description of Event or Problem · 1

    ANNUAL REPORT (2011) OF THE (B)(4) REGISTRY OF THE (B)(6) ASSOCIATION REPORTED A TOTAL OF THIRTEEN (13) REVISION PROCEDURES WERE PERFORMED BETWEEN 2004 AND 2010 TO REMOVE RECAP FEMORAL AND ACETABULAR COMPONENTS DUE TO LOOSENING/LYSIS, FRACTURE, INFECTION, PAIN & DISLOCATION. REPORT DID NOT CONTAIN SPECIFIC INFORMATION THAT WOULD CONFIRM WHETHER THE INFORMATION WAS PREVIOUSLY PROVIDED TO BIOMET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H10 PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R