BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 FP TYPE1 BM SO 11.0

    MDR report key: 8129528 · Received December 4, 2018

    Report

    Report Number
    0001825034-2018-11036
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    May 3, 2018
    Report Date
    August 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. RADIOGRAPH EVALUATION NOTED BONE QUALITY TO BE WITHIN THE NORMAL RANGE AND DID NOT IDENTIFY ANY COMPONENT MALFUNCTION; THE COMPONENTS ARE ANATOMICALLY ALIGNED, THERE IS NO FRACTURE, DISLOCATION, OR EVIDENCE OF COMPONENT LOOSENING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION TO REPORT

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 010000704, ITEM NAME: G7 BONEMASTER LTD ACET SHL 54F, LOT #: 3891187. ITEM NUMBER: 010000936, ITEM NAME: G7 HI-WALL E1 LINER 36MM F, LOT #: 3948380. ITEM NUMBER: 650-0662, ITEM NAME: DELTA CERAMIC FEM HD 36/+3MM, LOT #: 2016110730. ITEM NUMBER: 010000997, ITEM NAME: G7 SCREW 6.5MM X 20MM, LOT #: UNKNOWN. ITEM NUMBER: 010001001, ITEM NAME: G7 SCREW 6.5MM X 40MM, LOT #: UNKNOWN. THIS PRODUCT IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K101086. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 11033; 0001825034 - 2018 - 11034. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED MILD DEGREE OF PAIN AND GLUTEUS MEDIUS AND TENSOR FASCIA LATA TENDINOPATHY APPROXIMATELY 1 YEAR POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971062 TPRLC 133 FP TYPE1 BM SO 11.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3535144

    Patients

    Seq Age Sex Outcome Treatment
    1 Other