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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 12 MM
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 12 MM Back to Search Results
Model Number 02.07.0412FUC
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/08/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 october 2020: lot 092739: (b)(4) items manufactured and released on 16-dec-2009.Expiration date: 2014-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 1-1-2016.
 
Event or Problem Description
The patient had signs of infection and the pathogen is unknown.The surgeon performed a washout and poly-swap and the surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 12 MM
Common Device Name
TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10778508
Report Number3005180920-2020-00781
Device Sequence Number14396087
Product Code JWH
UDI-Device Identifier07630030817717
UDI-Public07630030817717
Combination Product (Y/N)Y
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/03/2020
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 Date10/31/2014
Device Model Number02.07.0412FUC
Device Catalogue Number02.07.0412FUC
Device Lot Number092739
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/08/2020
Initial Report FDA Received Date11/03/2020
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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