BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FMRL LAT NC 13X145MM

    MDR report key: 11290488 · Received February 7, 2021

    Report

    Report Number
    0001825034-2021-00374
    Event Type
    Injury
    Date Received
    February 7, 2021
    Date of Event
    June 10, 2020
    Report Date
    May 4, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00887868260599
    PMA / PMN Number
    K070274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THERE WAS A PRIMARY LEFT THA PERFORMED. AT A FOLLOW UP DOCTOR VISIT, IT IS NOTED THAT THE PATIENT WAS RECOVERING NORMALLY BUT WHEN VISITING WITH A PHYSIOTHERAPIST, THE PATIENT MORE VIGOROUSLY SET OUT TO PRACTICE RANGE OF MOTION WITH A PILATES ROLLER, AND FROM THIS THE HIP BECAME IRRITATED WITH POSTERIOR PAIN. THE PATIENT HAD PAIN AND INSTABILITY NOTED AFTER THIS EVENT IN WHICH AN MRI WAS DONE, WHICH PRODUCED RESULTS CONSISTENT WITH A RUPTURED TENDON AND ALSO SIGNIFIED CORRECT IMPLANT POSITON. THE PATIENT DID NOT RESPOND TO CONSERVATIVE TREATMENT AND UNDERWENT A TENDON. IT WAS NOTED THE FASCIA HAD BEEN CAUGHT IN THE TROCHANTER AND EXTERNAL ROTATORS AND THE PATIENT RECOVERED WELL FROM THE PROCEDURE. THE DEVICE WAS NOT REMOVED OR REPOSITIONED AND REMAINS IN PLACE. AS A PATIENT RECOVERS FROM IMPLANT SURGERY AN EXERCISE OR PT PROGRAM IS ROUTINELY PRESCRIBED IN ORDER FOR THE PATIENT TO RETURN TO AN OPTIMUM LEVEL OF FUNCTION. DURING THE POST- OPERATIVE PERIOD THE PATIENT IS ALSO RECOVERING FROM THE TRAUMA OF SURGERY AT VARYING RATES. BASED UPON THE INFORMATION PROVIDED, THE PATIENT WAS PARTICIPATING IN A PROGRAM AND WHILE PERFORMING MORE VIGOROUS ACTIVITIES AND APPEARS INJURED THEMSELVES WITH USE OF A ROLLER. UPON REVIEW OF THE ADDITIONAL INFORMATION, THE DEVICE WAS NOT REMOVED, THERE IS NO ALLEGATION TO THE DEVICE TO THIS EVENT THUS RULING OUT THE DEVICE AND SHOULD BE NON-REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A PRIMARY LEFT THA PERFORMED. AT A FOLLOW UP DOCTOR VISIT, IT IS NOTED THAT THE PATIENT WAS RECOVERING NORMALLY BUT WHEN VISITING WITH A PHYSIOTHERAPIST, THE PATIENT MORE VIGOROUSLY SET OUT TO PRACTICE RANGE OF MOTION WITH A PILATES ROLLER, AND FROM THIS THE HIP BECAME IRRITATED WITH POSTERIOR PAIN. THE PATIENT HAD PAIN AND INSTABILITY NOTED AFTER THIS EVENT IN WHICH AN MRI WAS DONE, WHICH PRODUCED RESULTS CONSISTENT WITH A RUPTURED TENDON AND ALSO SIGNIFIED CORRECT IMPLANT POSITON. THE PATIENT DID NOT RESPOND TO CONSERVATIVE TREATMENT AND UNDERWENT A TENDON. IT WAS NOTED THE FASCIA HAD BEEN CAUGHT IN THE TROCHANTER AND EXTERNAL ROTATORS AND THE PATIENT RECOVERED WELL FROM THE PROCEDURE. THE DEVICE WAS NOT REMOVED OR REPOSITIONED AND REMAINS IN PLACE. AS A PATIENT RECOVERS FROM IMPLANT SURGERY AN EXERCISE OR PT PROGRAM IS ROUTINELY PRESCRIBED IN ORDER FOR THE PATIENT TO RETURN TO AN OPTIMUM LEVEL OF FUNCTION. DURING THE POST- OPERATIVE PERIOD THE PATIENT IS ALSO RECOVERING FROM THE TRAUMA OF SURGERY AT VARYING RATES. BASED UPON THE INFORMATION PROVIDED, THE PATIENT WAS PARTICIPATING IN A PROGRAM AND WHILE PERFORMING MORE VIGOROUS ACTIVITIES AND APPEARS INJURED THEMSELVES WITH USE OF A ROLLER. UPON REVIEW OF THE ADDITIONAL INFORMATION, THE DEVICE WAS NOT REMOVED, THERE IS NO ALLEGATION TO THE DEVICE TO THIS EVENT THUS RULING OUT THE DEVICE AND SHOULD BE NON-REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). YEAR OF BIRTH: (B)(6). CONCOMITANT MEDICAL DEVICES: 163669 925900 32MM MOD HEAD COCR STD NECK; 010000666 651922 G7 PPS LTD ACET SHELL 58G; 010000851 6509364 G7 NEUTRAL E1 LINER 32MM G. FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE 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 - 2021 - 00375, 0001825034 - 2021 - 00376, 0001825034 - 2021 - 00377.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLINICAL STUDY PATIENT UNDERWENT PRIMARY TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED EXTERNAL ROTATOR MUSCLE RUPTURE AND UNDERWENT RE-SUTURE REPAIR APPROXIMATELY ONE YEAR POST IMPLANTATION. NO IMPLANTS WERE REMOVED OR EXCHANGED, AND REMAINS IMPLANTED. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187223 ECHO POR FMRL LAT NC 13X145MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 841050 00887868260599

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R