BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS LG M-H F SPINDLE 12MM PCHA 600LB ASSY

    MDR report key: 9549336 · Received January 3, 2020

    Report

    Report Number
    0001825034-2020-00059
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    May 19, 2010
    Report Date
    April 22, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K043547
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A HEMATOMA IS A MASS OF CLOTTED BLOOD THAT FORMS IN A TISSUE, ORGAN, OR BODY SPACE. A HEMATOMA CAN BE ASSOCIATED WITH PAIN, SWELLING, ECCHYMOSIS, SEROSANGUINOUS OR BLOODY DRAINAGE AFTER A RECENT SURGICAL PROCEDURE. THE DEVELOPMENT OF A POSTOPERATIVE HEMATOMA AFTER A PROCEDURE CAN BE CORRELATED WITH THE SURGICAL PROCEDURE AND PERIOPERATIVE ANTICOAGULATION THERAPY TO PREVENT DVT (PROPHYLAXIS). PATIENTS MAY BE AT INCREASED RISK FOR DEVELOPING HEMATOMAS IF THEY HAVE RECEIVED FRESH-FROZEN PLASMA, VITAMIN K, OR HORMONAL THERAPY AS WELL. MOST HEMATOMAS RESOLVE ON THEIR OWN, WITHOUT SURGICAL INTERVENTION, WHILE SOME OTHERS DO NOT. LARGER HEMATOMAS MAY NEED TO BE SURGICALLY EVACUATED IN ORDER TO RESOLVE. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED ZIMMER BIOMET DEVICE; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS WILL NOT BE PERFORMED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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: CPS ANCHOR PLUG 14MM, PN 178404, LN 794540, CPS TRANSVERSE PIN 6PK 32MM M, PN 178527, LN 088220, CPS TRANSVERSE PIN 6PK 36MM M, PN 178528, LN 156720, CPS CENTERING SLEEVE 16MM IA16MM, PN 178538, LN 477400, CPS NUT CO-CR-MO ALLOY, PN 178512, LN 814620, OSS 9CM DIAPHYSEAL SEGMENT, PN 150467, LN 766360, OSS FINN MOD PROX FMRL LT 7CM, PN 150458 LN 848680, OSS SEGMENTAL STACKING ADAPTER, PN 150483, LN 868140, CPS/OSS 5CM TPR ADAPT W/OSS SC 5CM, PN 178711, LN 314840, 36MM COCR MOD HD +3MM, PN 11-363663, LN 058080. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00055, 0001825034-2020-00056, 0001825034-2020-00057, 0001825034-2020-00058, 0001825034-2020-00060, 0001825034-2020-00061, 0001825034-2020-00062, 0001825034-2020-00063, 0001825034-2020-00064. 0001825034-2020-00065 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE 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 THAT THE PATIENT HAS A LONG HISTORY OF LEFT HIP COMPLICATIONS AND INFECTION. THE PATIENT UNDERWENT A REVISION OF A COMPETITORS FRACTURED CABLE. DURING THE REVISION, THE PATIENT WAS IMPLANTED WITH BIOMET COMPONENTS. SUBSEQUENTLY, THE PATIENT DEVELOPED A HEMATOMA AT THE SURGICAL SITE REQUIRING INCISION AND DRAINAGE. NO PRODUCT WAS EXCHANGED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11522 CPS LG M-H F SPINDLE 12MM PCHA 600LB ASSY PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 874940

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R