BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSDERMAL COMPRESS ADAPTER

    MDR report key: 8325071 · Received February 11, 2019

    Report

    Report Number
    0001825034-2019-00542
    Event Type
    Injury
    Date Received
    February 11, 2019
    Date of Event
    February 2, 2019
    Report Date
    May 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UDI # (B)(4). PATIENT'S INITIAL PMI FORM WAS LOCATED. THERE ARE TWO ADAPTERS LISTED OF DIFFERENT LENGTHS. IT IS UNKNOWN WHICH ONE WAS USED. THE 2ND TAPER ADAPTOR WHICH MIGHT HAVE BEEN USED IN TH SURGERY IS: PN: CP0001593 LN: 032830, MFG DATE: OCT 30, 2018, EXP DATE: OCT 30, 2028, UDI # (B)(4), 510K: EXEMPT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. CONCOMITANT MEDICAL PRODUCTS : CP0001590, TRNSDRML CMPRS SPNDL MD 800LB, 790040, CP0001591, TRNSDRML CMPRS SPNDL COLLAR MD, 183740, CP0001593, TRNSDRML CMPRS ADAPTER, 032830, CP0001594, TRNSDRML CMPRS ADAPTER PLUG, 032790, CP0001595, TRNSDRML ADAPTER END CAP, 784950, CP0001596, TRNSDRML ADAPTER SLEEVE, 780730, CP0001597, TRNSDRML FAILSAFE, 032730, CP0001598, TRNSDRML COLLAR IMPACTOR, 999120. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWO (2) MONTHS POST IMPLANTATION AS PATIENT IS A FEMORAL AMPUTEE THAT IS UNABLE TO WEAR A PROSTHETIC BECAUSE OF THE SOCKET AND LINER ISSUES, INCLUDING SKIN INFECTION, BACTERIA INFECTIONS, BLISTERS, BRUISES, AND OPEN WOUNDS REQUIRING WOUND CARE TREATMENTS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED POST SURGERY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE POST IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119298 TRANSDERMAL COMPRESS ADAPTER HIPS, PERSONALISED SOLUTION HSD ZIMMER BIOMET, INC. N/A 738340

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R