BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPB M-SERIES NECK HI OFFSET -5

    MDR report key: 6803164 · Received August 18, 2017

    Report

    Report Number
    1038671-2017-00579
    Event Type
    Injury
    Date Received
    August 18, 2017
    Date of Event
    August 9, 2017
    Report Date
    May 7, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    PMA / PMN Number
    K010120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT PRODUCTS WERE NOT RECEIVED FOR ANALYSIS. THE CONDITION OF LOOSENING WAS NOT CONFIRMED. THE FREQUENCY OF OCCURRENCE RANKING SCALE IS VERY LOW; THEREFORE, THIS DOES NOT APPEAR TO BE A DESIGN RELATED ISSUE. THE COMPANY IS NOT AWARE OF RECEIVING ANY COMPLAINT REPORTS INVOLVING ANOTHER PART FROM THIS MANUFACTURING LOT OF (B)(4) PIECES. COMPLAINT DATA FROM 2014 THROUGH 2018 INVOLVING THE REPORTED FAILURE FOR THIS FAMILY OF DEVICES WAS REVIEWED AND 1 SIMILAR COMPLAINT WAS FOUND. THE INVESTIGATION FOR THAT INCIDENCE HAS NOT IDENTIFIED ANY EVIDENCE THAT A MANUFACTURING ISSUE CAUSED OR CONTRIBUTED TO THIS REPORTED ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO A MANUFACTURING ISSUE. THE REPORTED EVENT WAS LIKELY THE RESULT OF ASEPTIC (NON-INFECTED) LOOSENING, WHICH DAMAGED THE BOND BETWEEN THE IMPLANT AND THE BONE. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION. IN A REVIEW OF THE LABELING, IT IS A KNOWN COMPLICATION THAT EXCESSIVE ACTIVITY AND TRAUMA AFFECTING JOINT REPLACEMENTS HAVE BEEN ASSOCIATED WITH PREMATURE FAILURE AND THAT FRACTURE, MIGRATION, LOOSENING, SUBLUXATION, OR DISLOCATION OF THE PROSTHESIS OR ANY OF ITS COMPONENTS, MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. ALSO, KNOWN COMPLICATION THAT A PATIENT'S AGE, WEIGHT, OR ACTIVITY LEVEL WOULD CAUSE THE SURGEON TO EXPECT EARLY FAILURE OF THE SYSTEM. REVISIONS OR SURGICAL INTERVENTIONS ARE A KNOWN COMPLICATION FOUND IN JOINT REPLACEMENTS. ALL PATIENTS SHOULD BE INSTRUCTED ON THE LIMITATIONS OF THE PROSTHESIS, THE PATIENT SHOULD BE CAUTIONED TO MONITOR ACTIVITIES AND PROTECT THE REPLACED JOINT FROM UNREASONABLE STRESSES AND FOLLOW THE WRITTEN INSTRUCTIONS OF THE PHYSICIAN WITH RESPECT TO FOLLOW-UP CARE AND TREATMENT. A CLINICAL FACTOR IS THE PATIENTS' AGE, YOUNG PATIENTS ARE MORE ACTIVE AND CAN CREATE MORE THAN EXPECTED BIOMECHANICAL STRESSORS FOR THE IMPLANTS. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. IN THE INVESTIGATION OF THIS COMPLAINT, INFORMATION HAS BEEN REQUESTED ABOUT THE PATIENT AND EVENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT COMPLAINED OF HIP PAIN AND WAS REVISED. THE LINER WAS REVISED FROM A 28MM TO A 32MM FOR ADDED STABILITY. THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED ON THE PATIENT OR EVENT. THIS IS ONE OF FIVE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1038671-2017-00575, 1038671-2017-00576, 1038671-2017-00577, 1038671-2017-00578 .

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    REVISION OF HIP COMPONENTS DUE TO ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583275 LPB M-SERIES NECK HI OFFSET -5 NECK SEGMENT JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention