BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR 6.5X35 SELF-TAP

    MDR report key: 9385627 · Received November 27, 2019

    Report

    Report Number
    0002648920-2019-00867
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    November 5, 2019
    Report Date
    April 28, 2020
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K151907
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00223200418- CABLE CERCLAGE CABLE- 63989795, 11-301322-ARCOS CON-474370, 11-301000- MOD FEMORAL PROX-810870, 010000663- G7 PPS LTD ACET SHELL- 6289244, 110024463- G7 DUAL MOBILITY LINER- 690310, 11-300815- ARCOS 15X150MM SPL TPR- 351720, 12-115110- CER BIOLOXD MOD- 2912205, EP-200148 ACT ARTIC E1 HIP BRG 28X42MM LOT# 017610. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-05094. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY. APPROXIMATELY 26 DAYS LATER PATIENT WAS REVISED DUE TO INFECTION. ONE YEAR LATER PATIENT WAS REVISED DUE TO BODY SPUN OUT. THREE MONTHS LATER PATIENT WAS REVISED AGAIN WHERE ALL IMPLANTS WERE REMOVED DUE TO INFECTION, DUE TO CONTINUED INFECTION ON THE LAST ONE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177457 BONE SCR 6.5X35 SELF-TAP PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 63651675

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R