BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 FP TYPE1 PPS HO 7.0 T1

    MDR report key: 9475112 · Received December 16, 2019

    Report

    Report Number
    0001825034-2019-05574
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    November 21, 2019
    Report Date
    May 6, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS/RADIOGRAPHS IDENTIFIED THE FOLLOWING: PAIN 7/10 TROCHANTER & BUTTOCK ARE SEVERE, PAIN OCCURS WITH FIRST STEPS AND THEN GETS BETTER. TAKING OTC NSAIDS DAILY. NO LIMP, NO CANE, INCREASED ADLS, WALKS 6 BLOCKS . NO ADVERSE EVENTS REPORTED TO DATE. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110024460 G7 DUAL MOBILITY LINER 36MM 778940, 010000991 ACT ARTIC E1 HIP BRG 22X36MM 344600, 163651 22.2MM DIA COCR MOD HD STD NK 745430, 110010241 G7 OSSEOTI 3 HOLE SHELL 46MM 3791390. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2019 -05571 LINER, 0001825034 -2019 -05572 BEARING, 0001825034 -2019 -05573 HEAD, 0001825034 -2019 -05575 SHELL.

    Description of Event or Problem · 1

    A STUDY PATIENT HAD AN INITIAL LEFT THA AND SUBSEQUENTLY, AT THE ONE YEAR FOLLOW UP VISIT PATIENT REPORTS SEVERE TROCHANTER AND BUTTOCK PAIN, WITH AN OVERALL PAIN LEVEL OF 7 OUT OF 10. THE PATIENT TAKES OVER THE COUNTER NSAIDS DAILY. OTHER CLINICAL MEASURES SUCH AS ADLS AND ROM HAVE EITHER IMPROVED OR REMAINED WITHIN NORMAL LIMITS COMPARED TO PREOP. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268026 TPRLC 133 FP TYPE1 PPS HO 7.0 T1 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6268317

    Patients

    Seq Age Sex Outcome Treatment
    1 Other