BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A ACETABULAR COMPONENT

    MDR report key: 7538563 · Received May 23, 2018

    Report

    Report Number
    0001825034-2018-03391
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    November 11, 2016
    Report Date
    July 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVIEW OF INVOICE HISTORY WAS UNABLE TO DETERMINE THE EXACT IDENTIFICATION OF THE DEVICE INVOLVED IN THE REPORTED EVENT. THIS REPORT IS ADDITIONALLY BEING SUBMITTED FOR THE FOLLOWING ACETABULAR DEVICES: CATALOG# 10-104058, M2A-T M/H RAD 2HL, LOT# 870450. CATALOG# 10-104062, HEAD, LOT# 846650. CONCOMITANT MEDICAL PRODUCTS: CATALOG# RD118856, M2A 38MM CUP, LOT# 330980 OR CATALOG# 15-105004, M2A TAPER LINER, LOT# 963340 CATALOG# 103203, TAPERLOC POR FMRL 9X137, LOT# 305410 OR CATALOG# 162307, BI-METRIC CDH POR N/C 7X114, LOT# 966440 CATALOG# 11-173660, HEAD, LOT# 430130 OR CATALOG# 11-163667, HEAD, LOT#335980. MULTIPLE MDR'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 0001825034-2018-03392. 0001825034-2018-03711.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. CONTRIBUTING FACTORS ARE DEGENERATIVE JOINT DISEASE SECONDARY TO CHILDHOOD HIP DISEASE. PATIENT HAS SIGNIFICANT LIMITATION OF MOTION OF HER RIGHT HIP AND SEVERE PAIN ATTRIBUTED TO HISTORY OF MULTIPLE SURGERIES ON THE RIGHT HIP AS A CHILD. POOR BONE QUALITY AND PATIENT ANATOMY WITH EXTENSIVE DIFFICULTY PLACING COMPONENTS IN INITIAL SURGERY. 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.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 162307 ¿ BI-METRIC FEMORAL STEM ¿ 966440, 11-173660 ¿ M2A MODULAR HEAD ¿ 430130, 113845 - LOW PROFILE SCREW - 426960, 113846 - LOW PROFILE SCREW - 255104, 113847 - LOW PROFILE SCREW - 297849, 113845- LOW PROFILE SCREW - 454210. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 00863, 0001825034 - 2019 - 00866, 0001825034 - 2019 - 00869, 0001825034 - 2019 - 00870, 0001825034 - 2019 - 00871.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SECOND REVISION, THE PATIENT EXPERIENCING APPROXIMATELY 1000 ML OF BLOOD LOSS AND RECEIVED 225 ML AUTOLOGOUS RED BLOOD CELLS FROM CELL SAVER REINFUSED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A SECOND RIGHT HIP REVISION APPROXIMATELY 12 YEARS POST IMPLANTATION DUE TO PAIN, DISLOCATION, METALLOSIS, AND PAINFUL SHORTENED LEG. DURING THE SURGERY, THE FEMORAL STEM WAS NOTED TO HAVE EXTENSIVE AMOUNT OF PROXIMAL BONE LOSS RIDING HIGH IN THE SOFT TISSUES. LARGE COLLECTION OF SEROUS FLUID WAS FOUND ALONG WITH LOOSE RIM SCREWS AND ACETABULAR CUP FOUND WITHIN THE SOFT TISSUES. EXTENSIVE METALLOSIS WAS FOUND AROUND THE ACETABULUM.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 0001825034-2018-03392. REVIEW OF INVOICE HISTORY WAS UNABLE TO DETERMINE THE EXACT IDENTIFICATION OF THE DEVICE INVOLVED IN THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED FOR: BRAND NAME ¿ M2A 38MM CUP; CATALOG NUMBER ¿ RD118856; LOT NUMBER ¿ 330980; EXPIRATION DATE ¿ NOV 30, 2013; PMA/510(K) NUMBER ¿ K011110; DEVICE MANUFACTURE DATE - NOV 18, 2003. OR BRAND NAME ¿ M2A TAPER LINER 32MM ID SIZE 41MM OD; CATALOG NUMBER ¿ 15-105004; LOT NUMBER ¿ 963340; EXPIRATION DATE ¿ MAR 31, 2014; PMA/510(K) NUMBER ¿ K082446; DEVICE MANUFACTURE DATE - MAR 1, 2004. CONCOMITANT MEDICAL PRODUCTS: CATALOG# 11-163667, FEMORAL HEAD, LOT# 335980 OR CATALOG# 11-173660, FEMORAL HEAD, LOT# 430130. CATALOG# 103203, TAPERLOC POR FMRL 9X137, LOT# 305410 OR CATALOG# 162307, BI-METRIC CDH POR N/C 7X114, LOT# 966440. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR FOR BOTH DEVICES 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 · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380752 M2A ACETABULAR COMPONENT PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R