BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD +3MM NK

    MDR report key: 8276934 · Received January 25, 2019

    Report

    Report Number
    0001825034-2019-00271
    Event Type
    Injury
    Date Received
    January 25, 2019
    Report Date
    September 13, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS RECEIVED. OPERATIVE NOTES DEMONSTRATED THAT THE PATIENT EXPERIENCED PAIN AND LIMITED RANGE OF MOTION. AFTER PHYSICAL THERAPY, THE PATIENT WAS ABLE TO WALK INDEPENDENTLY, WITH FULL SUPPORT, NO PAIN. AT THE END OF THE SESSIONS, THE PATIENT WAS AT 90° FLEXION, 10° EXTENSION AND 15° ABDUCTION, AND THE PATIENT WAS ABLE TO DRESS INDEPENDENTLY, CARRY OUT HYGIENE AND FEEDING, AND WAS DISCHARGED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS : 11-105903,ARCOM 28MM RNGLOC LNR HWALL 23 460670, X180310, BI-METRIC/X POR NC 10X130, 781600, 12-104152, M/H RADIAL 3-HOLE SHELL 52MM, 599860.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE THREE MONTHS AGO. SUBSEQUENTLY PATIENT IS EXPERIENCING PAIN, LIMITED RANGE OF MOTION AND MOBILITY. THE PATIENT WAS PRESCRIBED 8 SESSIONS OF PHYSICAL THERAPY. IT WAS REPORTED THAT THE PATIENT IS UNABLE TO BEND MORE THAN 90 DEGREES.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-105903, ARCOM 28MM RNGLOC LNR HWALL 23, UNK; X180310, BI-METRIC/X POR NC 10X130, UNK; 12-104152, M/H RADIAL 3-HOLE SHELL 52MM, UNK. (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00269. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, REMAINS IMPLANTED. 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 UNDERWENT RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE THREE MONTHS AGO. SUBSEQUENTLY PATIENT IS EXPERIENCING LIMITED RANGE OF MOTION AND MOBILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71926 28MM DIA COCR MOD HD +3MM NK PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 238570

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R