BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO B-MTRC MP FP HO 8

    MDR report key: 9938376 · Received April 8, 2020

    Report

    Report Number
    0001825034-2020-01503
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    March 12, 2020
    Report Date
    August 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K143009
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; E1; E2; E3; E4; G3; G4; H2; H3; H4; H6. REPORTED EVENT WAS CONFIRMED. MEDICAL AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FOLLOW UP VISIT FOR LEFT HIP PAIN DESCRIBED AS DULL SORENESS AND STIFFNESS TO THE LEFT HIP THAT IS WORSE AFTER SITTING IN THE SAME POSITION FOR A LONG TIME, WITH HEAVINESS. PREVIOUS TREATMENT DID HELP. ALSO STATES PAIN INCREASES WITH ACTIVITY. ASSESSMENT APPEARS TO BE WITHIN NORMAL LIMITS AS WELL AS X-RAYS. PLAN TO RULE OUT INFECTION WITH BLOOD TESTING. TWO YEAR FOLLOW UP VISIT PATIENT CONTINUES TO HAVE TO HAVE DULL SORENESS AND STIFFNESS TO LEFT HIP WORSE AFTER SITTING IN SAME POSITION FOR A LONG TIME BUT IMPROVED OVER LAST TIME. X-RAYS CONTINUE TO SHOW WELL POSITIONED IMPLANTS. NO TREATMENT ORDERED. ONE YEAR LATER ONGOING SYMPTOMS WITH LEFT HIP. ASSESSMENT CONTINUES TO BE WITHIN NORMAL LIMITS AS WELL AS IMAGING. ORDERS NOTED FOR L-SPINE MRI EVALUATION FOR L3-L4 SPINAL STENOSIS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT FOR ITEMS 010000856 AND 010000662. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 010000662-G7 PPS LTD ACET SHELL 50D-6149828; 010000856- G7 NEUTRAL E1 LINER 36MM D-6025178; 650-1057-CER BIOLOXD OPTION HD 36MM-2904536. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 01498, 0001825034 - 2020 - 01501. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT 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 IS EXPERIENCING INCREASED PAIN 2 YEARS POST IMPLANTATION. A BONE SCAN WAS PERFORMED AND MRI PLANNED. NO FURTHER INTERVENTION HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402718 ECHO B-MTRC MP FP HO 8 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 66931OR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10