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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 4 / 10 MM; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 4 / 10 MM; KNEE TIBIAL INSERT Back to Search Results
Model Number 02.07.0410SF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 08/13/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09-sep-2020: lot 1902778: (b)(4) items manufactured and released on 03-jul-2019.Expiration date: 15.06.2024.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.
 
Event or Problem Description
The patient came in due to signs of an infection 2 months after the primary surgery, the pathogen is unknown.The surgeon performed a washout and revised the liner.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 4 / 10 MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10507050
Report Number3005180920-2020-00599
Device Sequence Number16902487
Product Code JWH
UDI-Device Identifier07630030817663
UDI-Public07630030817663
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
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) 09/09/2020
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 Date06/15/2024
Device Model Number02.07.0410SF
Device Catalogue Number02.07.0410SF
Device Lot Number1902778
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/13/2020
Initial Report FDA Received Date09/09/2020
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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