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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/26MM
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MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/26MM Back to Search Results
Model Number 02.07.0226SCF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/21/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 july 2021: lot 189530: (b)(4) items manufactured and released on 08-jan-2019.Expiration date: 2023-12-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.About 10 months after primary the surgeon performed a washout and revised the poly and the surgery was completed successfully.
 
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Brand Name
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/26MM
Common Device Name
TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12157275
Report Number3005180920-2021-00579
Device Sequence Number14606500
Product Code JWH
UDI-Device Identifier07630030816987
UDI-Public07630030816987
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K103170
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date12/18/2023
Device Model Number02.07.0226SCF
Device Catalogue Number02.07.0226SCF
Device Lot Number189530
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/21/2021
Initial Report FDA Received Date07/13/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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