BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 58G

    MDR report key: 7295881 · Received February 26, 2018

    Report

    Report Number
    0001825034-2018-01439
    Event Type
    Injury
    Date Received
    February 26, 2018
    Date of Event
    January 30, 2017
    Report Date
    March 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01438. CONCOMITANT PRODUCT(S): A 192112 ECHO POR FMRL LAT NC 12X140MM LOT 876340; 650-1162 DELTA CER FEM HD 32/0MM T1 LOT 2016031399; 110003629 BIOLOX DELTA CER LNR 32MM G LOT 3409702. REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN (B)(6). THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN DETERMINED THAT THIS EVENT IS NOT REPORTABLE AND THE INITIAL MEDWATCH WAS SUBMITTED IN ERROR. PLEASE VOID THIS ENTRY.

    Description of Event or Problem · 1

    CLINICAL STUDY 518 REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP REPLACEMENT. AT THE 3-MONTH POST-OP VISIT THE PATIENT EXPERIENCED - PROBLEMS WASHING, DRESSING/PERFORMING USUAL ACTIVITIES, MODERATE PAIN. HARRIS - MODERATE, TOLERABLE MAKES CONCESSIONS TO PAIN, SOME LIMITATION OF ORDINARY ACTIVITY OR WORK. MAY REQUIRE OCCASIONAL PAIN MEDICINE STRONGER THAN ASPIRIN. MODERATE LIMP, USES A CANE MOST OF THE TIME. (B)(6) - SEVERE PAIN, MODERATE TROUBLE WASHING/DRYING, MODERATE TROUBLE GETTING IN OR OUT OF CAR, EXTREMELY DIFFICULT TO PUT ON SOCKS, IMPOSSIBLE TO SHOP, EXTREMELY DIFFICULT TO CLIMB STAIRS, OFTEN LIMPING, MODERATELY PAINFUL TO STAND UP, LIMPING ALL OF THE TIME, PAIN HAS GREATLY INTERFERED WITH WORK. PAIN IN BED MOST NIGHTS. PAIN SCALE: FIVE WHEN MOVING AND AT REST. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139036 G7 PPS LTD ACET SHELL 58G PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3789267

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R