BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRNSDRML CMPRS SPNDL COLLAR MD

    MDR report key: 9716759 · Received February 17, 2020

    Report

    Report Number
    0001825034-2020-00731
    Event Type
    Injury
    Date Received
    February 17, 2020
    Report Date
    July 24, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G4; G7; H1; H2; H3; H6. AS DISCOVERED VIA DUE DILIGENCE AND INVESTIGATION, THIS PATIENT SLIPPED EXITING A MOVIE THEATRE AND FELL CAUSING DAMAGE TO THE DEVICE AND CASCADING EVENTS OF MYODESIS FAILURE AND INFECTION. THIS WOULD OCCUR AS THE TISSUES OF THE SKIN & MUSCLE STUMP FLAP (MYODESIS) WAS DAMAGED FROM THE IMPACT OF THE FALL LEADING TO FAILURE AND SUBSEQUENT INFECTION. THIS INFORMATION COMES VIA DIRECT CORRESPONDANCE FROM THE PATIENT SME, THE SURGEON SEE (B)(4).THE DEVICE DID NOT FAIL. THERE WAS NO INSTABILITY OR MALFUNCTION. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE FALL. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE CASCADING EVENTS OF MYODESIS FAILURE OR INFECTION. THESE EVENTS WERE ALSO NOT RELATED TO THE PROCEDURE AS THE INITIAL IMPLANTATION WAS (B)(6) 2018.

    Description of Event or Problem · 0

    THE SURGEON REPORTS THE PATIENT DAMAGED THE IMPLANT WHEN HE SLIPPED EXITING A MOVIE THEATER. THE TISSUE THEN BECAME INFECTED AFTER SUSTAINING A MYODESIS FAILURE INVOLVING THE SOFT TISSUE COLLAR.

    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: ITEM#:UNKNOWN; UNKNOWN COMPRESS ADAPTER; LOT#:UNKNOWN, ITEM#:CP0001590; TRNSDRML CMPRS SPNDL MD 800LB; LOT# 790040, ITEM#:CP0001597; TRNSDRML FAILSAFE; LOT# 032730, ITEM#:CP0001594; TRNSDRML CMPRS ADAPTER PLUG; LOT# 032790, ITEM#:CP0001595; TRNSDRML ADAPTER END CAP; LOT# 784950, ITEM#:CP0001596; TRNSDRML ADAPTER SLEEVE; LOT# 780730, ITEM#:CP0001598; TRNSDRML COLLAR IMPACTOR; LOT# 999120. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT IS STILL 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: 0001825034-2020-00732.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO CURRENTLY HAS A PMI TRANSDERMAL COMPRESS DEVICE IMPLANTED APPROXIMATELY 13 MONTHS AGO, HAS FALLEN, DAMAGING THE IMPLANTS. PATIENT IS BEING CONSIDERED FOR REVISION; HOWEVER, REVISION HAS NOT OCCURRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180936 TRNSDRML CMPRS SPNDL COLLAR MD PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 183740

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other SEE H10.