BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD +12MM NK SKRT

    MDR report key: 9633448 · Received January 27, 2020

    Report

    Report Number
    0001825034-2020-00399
    Event Type
    Injury
    Date Received
    January 27, 2020
    Date of Event
    January 20, 2020
    Report Date
    March 10, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G4; H2; H3; H6 REPORTED EVENT WAS CONFIRMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: (SUMMARIZED BY HCP) DX: PAINFUL LEFT THA, PROBABLE METALLOSIS, BROKEN FIXATION SCREW. WORKUP FOR INFECTION NEGATIVE, CRP <5.0, METAL IONS ELEVATED, MRI SHOWED FLUID COLLECTION WITH AN OVERALL APPEARANCE OF METALLOSIS. LARGE AMOUNT OF DARK SANGUINEOUS FLUID PRESENT, MODERATE METAL STAINING IN THE SYNOVIAL TISSUES AND BONE SURFACE OF THE ACETABULUM, RIM SCREW BROKEN, SCANT IF ANY OSSEOUS INTEGRATION ON THE BACK OF THE ACETABULUM, FEMORAL COMPONENT WELL FIXED. MODEST TO MODERATE WEAR ON THE TRUNNION AND METALLIC DEBRIS WITHIN THE FEMORAL HEAD SUGGESTED THAT TRUNNIONOSIS WAS INDEED THE LIKELY CAUSE OF METAL DEBRIS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE M2A 38MM MOD HD +12MM NK SKRT ITEM# 11-173666 LOT# 140670 WAS RETURNED AND EVALUATED. THE HEAD HAD A WEAR LINE AND SCUFFING ON THE OUTSIDE DIAMETER. THE TAPER OF THE HEAD HAD DEBRIS INSIDE. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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

    D11: 15-105056-M2A 1 PC SHELL 38MMX56MM-831000; UNKNOWN-UNKNOWN STEM-UNKNOWN. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON REPORTED EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION SURGERY 12 YEARS POST IMPLANTATION DUE TO PAIN AND SUSPECTED METALLOSIS ON MRI. DURING THE REVISION, SIGNIFICANT BLACK STAINING FROM TRUNNIONOSIS WAS NOTED. THE ACETABULAR SHELL WAS REPLACED DUE TO A BROKEN RIM SCREW AND VERY LITTLE OSSEOINTEGRATION ON THE BACK OF THE SHELL. THE STEM WAS WELL-FIXED AND LEFT INTACT. ALL OTHER COMPONENTS WERE REPLACED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00398. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP ARTHROPLASTY ON AN UNKNOWN DATE, SUBSEQUENTLY, THE PATIENT WAS REVISED FOR PAIN AND ELEVATED ION LEVELS. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95984 M2A 38MM MOD HD +12MM NK SKRT PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 140670
    95985 M2A 38MM MOD HD +12MM NK SKRT PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 140670

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization| R SEE H10| UNKNOWN CUP, PN UNKNOWN, LN UNKNOWN| UNKNOWN STEM, PN UNKNOWN, LN UNKNOWN