BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL POROUS WITH CLUSTER HOLES

    MDR report key: 6595604 · Received May 26, 2017

    Report

    Report Number
    0001822565-2017-03617
    Event Type
    Injury
    Date Received
    May 26, 2017
    Report Date
    January 9, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK093561
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS - ACETABULAR LINER CATALOG#: 00631005832 LOT#: 62863712, FEMORAL STEM CATALOG#: 00771101120 LOT#: 61986056, CERAMIC FEMORAL HEAD CATALOG#: 00877703202 LOT#: 2798773. AS PRODUCT ID CANNOT BE CONFIRMED THE FOLLOW FIELDS COULD BE: SHELL POROUS WITH CLUSTER HOLES 58 MM O.D., PART NUMBER - 00620005822, LOT NUMBER - 62036864, EXPIRATION DATE - JUN 9, 2022 , K934765, MANUFACTURING DATE - JUN 11, 2012. OR SHELL POROUS WITH CLUSTER HOLES 58 MM, PART NUMBER - 00620205822, LOT NUMBER - 62076173, EXPIRATION DATE - MAY 31, 2022, K093561, MANUFACTURING DATE - JUN 4, 2012. 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: 0001822565-2017-03614, 0001822565-2017-03617, 0001822565-2017-03618.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 58 MM O.D. SHELL CATALOG#: 00631005832 LOT#: 62863712 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 11 EXTENDED OFFSET CATALOG#: 00771101120 LOT#: 61986056 BIOLOX® OPTION, HEAD, M, ø 32/0, TAPER 12/14 CATALOG#: 00877703202 LOT#: 2798773 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 THAT PATIENT EXPERIENCES LIMITED MOBILITY AND MUST USE A WALKING STICK APPROXIMATELY FIVE YEARS POST-IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374423 SHELL POROUS WITH CLUSTER HOLES PROSTHESIS, HIP LPH ZIMMER, INC. N/A 62076173

    Patients

    Seq Age Sex Outcome Treatment
    1 Other