BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSEPH LT FS RASP 11 X 95

    MDR report key: 14453177 · Received May 20, 2022

    Report

    Report Number
    0001825034-2022-01242
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 26, 2022
    Report Date
    June 14, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDH
    UDI-DI
    00887868554322
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PM0003872-JOSEPH LT PRIMARY HIP 11 X 95-759110, 01.00561.214-WAGN CONE PROSTHESIS 125/14-3013904, 01.00561.217-WAGN CONE PROSTHESIS 125/17-759110. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H3; H6 H6 COMPONENT CODE: MECHANICAL (G04) ¿ RASP ONE JOSEPH LT FS RASP 11 X 95 ITEM# PM0003873 LOT# 759370 AND ONE BROACH HANDLE ITEM# 429886 LOT# 510870 WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE BROACH HANDLE HAD AN IMPACT MARK ON THE BODY NEAR THE STRIKE PLAT AND ON THE STRIKE PLATE FLAT. THE RETURNED BROACH HAD SCRATCHES NEAR THE LOCKING POSITION ON THE TAPER WITH NO OTHER VISIBLE DAMAGE. THE BROACH WAS ABLE TO BE ATTACHED TO THE HANDLE AND DID NOT MOVE ONCE LOCKED IN PLACE UNTIL THE RELEASE BUTTON WAS PRESSED. DIMENSIONAL ANALYSIS WAS PERFORMED AND FOUND TO BE CONFORMING. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS AND RADIOGRAPHS WERE REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES; A CUSTOM ZB FEMORAL STEM WAS ORDERED DUE TO THE PATIENT'S SMALL STATURE AND FEMORAL ABNORMALITIES. IN ADDITION TO THE SMALL STATURE REQUIRING A CUSTOM MICRO STEM, FEMORAL ABNORMALITIES, AND SIGNIFICANTLY HIGH BMI >42, FEMORAL RETRACTING, JOINT VISUALIZATION, AND IMPLANT/INSTRUMENT PLACEMENT DIFFICULTIES WOULD BE SIGNIFICANTLY INCREASED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CUSTOM CT WAS OBTAINED FOR A CUSTOM LEFT HIP PROSTHESIS. THE CUSTOM BROACH HANDLE DESIGNED WAS TOO LARGE FOR THE PATIENT'S ANATOMY TO EFFECTIVELY NAVIGATE THE FEMORAL CANAL IN THE PROPER ORIENTATION. DUE TO THIS, A SEPARATE IMPLANT WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923544 JOSEPH LT FS RASP 11 X 95 PROSTHESIS, HIP JDH ZIMMER BIOMET, INC. N/A 759370 00887868554322

    Patients

    Seq Age Sex Outcome Treatment
    1 Female