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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE UC FIXED TIBIAL INSERT SIZE 2/20MM
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MEDACTA INTERNATIONAL SA GMK-HINGE UC FIXED TIBIAL INSERT SIZE 2/20MM Back to Search Results
Model Number 02.09.0220UCH
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/03/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 september 2020, lot: 183630: (b)(4) items manufactured and released on (b)(6) 2018.Expiration date: 2023-07-24.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.
 
Event or Problem Description
The patient had signs of infection and the pathogen was staphylococcus aureus.The surgeon revised the liner and the surgery was completed successfully.This is the third surgery for infection on this patient.The primary surgery was on (b)(6) 2020.
 
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Brand Name
GMK-HINGE UC FIXED TIBIAL INSERT SIZE 2/20MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10600392
Report Number3005180920-2020-00675
Device Sequence Number19737946
Product Code KRO
UDI-Device Identifier07630030879227
UDI-Public07630030879227
Combination Product (Y/N)Y
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K172347
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 09/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Expiration Date07/24/2023
Device Model Number02.09.0220UCH
Device Catalogue Number02.09.0220UCH
Device Lot Number183630
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/03/2020
Initial Report FDA Received Date09/29/2020
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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