BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM LINER STANDARD OFFSET

    MDR report key: 6609085 · Received June 2, 2017

    Report

    Report Number
    0001822565-2017-03782
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    May 22, 2017
    Report Date
    January 22, 2020
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK002960
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: FEMORAL HEAD PN 00902603614/ LN 60006248. SHELL POROUS WITH MULTI HOLES 70 MM/ PN 00620207020/ LN 60336796. BONE SCR 6.5X20 SELF-TAP/ PN 00625006520/ LN 61226925. BONE SCR 6.5X35 SELF-TAP/ PN 00625006535/ PN 61378465. BONE SCR 6.5X45 SELF-TAP/ PN 00625006545/ LN 61320021. BONE SCR 6.5X25 SELF-TAP/ PN 00625006525/ LN 61313662. BONE SCR 6.5X35 SELF-TAP/ PN 00625006535/ LN 61357475. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001822565-2017-03783.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: UNKNOWN BIAS STEM FEMORAL HEAD, PN 00902603614/ LN 60006248; SHELL POROUS WITH MULTI HOLES 70 MM/ PN 00620207020/ LN 60336796; BONE SCR 6.5X20 SELF-TAP/ PN 00625006520/ LN 61226925; BONE SCR 6.5X35 SELF-TAP/ PN 00625006535/ PN 61378465; BONE SCR 6.5X45 SELF-TAP/ PN 00625006545/ LN 61320021; BONE SCR 6.5X25 SELF-TAP/ PN 00625006525/ LN 61313662; BONE SCR 6.5X35 SELF-TAP/ PN 00625006535/ LN 61357475. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001822565-2017-03783, 0001822565-2017-03782, 0001822565-2017-08099. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. RADIOGRAPH FINDINGS INDICATE THAT THE ACETABULAR CUP IS OVERSIZED, PROTRUDING BEYOND THE ANTERIOR LATERAL MARGIN OF THE NATIVE ACETABULUM, WHICH MAY PREDISPOSE TO IMPINGEMENT. ACETABULAR CUP HORIZONTAL CENTER OF ROTATION IS LATERALIZED, WHICH INCREASES RISK OF DISLOCATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO DISLOCATION APPROXIMATELY SEVEN YEARS POST IMPLANTATION. THERE WERE NO COMPLICATIONS OR DELAY REPORTED.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THERE WAS CORROSION NOTED ON THE TAPER OF THE HEAD. DISLOCATION WAS NOTED ON AN X-RAY REVIEW. MEDICAL RECORDS FURTHER REPORT THAT THE PATIENT HAS PAIN AND A MASS IN THE PELVIC REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389957 TRILOGY ACETABULAR SYSTEM LINER STANDARD OFFSET PROSTHESIS, HIP LPH ZIMMER, INC. N/A 61100702

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R