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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 3/12MM; KNEE FIXED TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 3/12MM; KNEE FIXED TIBIAL INSERT Back to Search Results
Model Number 02.09.0312H
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 12/22/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 january 2021: lot 1904692: (b)(4) items manufactured and released on 03-july-2019.Expiration date: 2024-06-11.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
Revision surgery due to infection 1 month after the primary and the pathogen is unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.
 
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Brand Name
GMK-HINGE FIXED TIBIAL INSERT SIZE 3/12MM
Common Device Name
KNEE FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11207400
Report Number3005180920-2021-00057
Device Sequence Number3373034
Product Code KRO
UDI-Device Identifier07630030825125
UDI-Public07630030825125
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K130299
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) 01/21/2021
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 Date06/11/2024
Device Model Number02.09.0312H
Device Catalogue Number02.09.0312H
Device Lot Number1904692
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/22/2020
Initial Report FDA Received Date01/21/2021
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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