BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 T1 PPS SO 16X152MM T1

    MDR report key: 15075410 · Received July 21, 2022

    Report

    Report Number
    0001825034-2022-01666
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    June 27, 2022
    Report Date
    August 12, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304489691
    PMA / PMN Number
    K200196
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 650-1163- DELTA CER FEM HD 32/-3MM T1- 3103857, 51-103160- TPRLC 133 T1 PPS SO 16X152MM- 6161620, 00632006032- MODULAR CUP 20 DEGREE LINER LONGEVITY 60X32- 64240050, 00620206022- TM MODULAR CUP 60MM CLUSTER-HOLE- 64553159, 51-103160- TPRLC 133 T1 PPS SO 16X152MM- 6537240, 650-1161- DELTA CER FEM HD 32/+3MM T1-3090603. 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: D4; G3; H2; H3; H4; H6 H6 COMPONENT CODE: MECHANICAL (G04) - STEM VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE STEM IS SEIZED TO THE RETURNED CERAMIC HEAD. VISUAL INSPECTION FOUND THE STEM TO BE IN GOOD OVERALL CONDITION. IMPACT MARKS ARE PRESENT ON THE SHOULDER AND NECK. A SMALL AMOUNT OF DEBRIS WAS OBSERVED IN THE POROUS COATING ON THE STEM'S SPINE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 STEM AND HEAD WERE IMPLANTED. AFTER REDUCING, SURGEON WANTED TO CHANGE HEAD SIZES. A TAMP WAS INTRODUCED AND ATTEMPTED TO REMOVE IMPLANTED HEAD. SUBSEQUENTLY, THE HEAD WOULD NOT FREE FROM STEM. HAD TO REMOVE STEM AND HEAD AS A MONOBLOCK CONSTRUCT. 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
    1435057 TPRLC 133 T1 PPS SO 16X152MM T1 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 6161620 00880304489691

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown