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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 10 MM; KNEE TIBIAL INSET
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 10 MM; KNEE TIBIAL INSET Back to Search Results
Model Number 02.07.0510SF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/14/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 january 2020: lot 1811637: (b)(4) items manufactured and released on 15.05.2019.Expiration date: 2024-05-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.
 
Event or Problem Description
Revision surgery performed 3 months after the primary due to signs of an 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 STD FIXED SIZE 5 / 10 MM
Common Device Name
KNEE TIBIAL INSET
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9693700
Report Number3005180920-2020-00043
Device Sequence Number16749660
Product Code JWH
UDI-Device Identifier07630030818240
UDI-Public07630030818240
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/11/2020
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 Date05/01/2024
Device Model Number02.07.0510SF
Device Catalogue Number02.07.0510SF
Device Lot Number1811637
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/14/2020
Initial Report FDA Received Date02/11/2020
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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