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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE 02.09.0214H FIXED TIBIAL INSERT SIZE 2/14MM; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-HINGE 02.09.0214H FIXED TIBIAL INSERT SIZE 2/14MM; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.09.0214H
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/11/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 february 2019.Lot 181574: (b)(4) items manufactured and released on 28 june 2018.Expiration date: 2023-06-11.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
About 2 months after primary the surgeon revised the patient knee for infection.I&d and insert swap performed successfully.
 
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Brand Name
GMK-HINGE 02.09.0214H FIXED TIBIAL INSERT SIZE 2/14MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8319911
Report Number3005180920-2019-00044
Device Sequence Number2285408
Product Code KRO
UDI-Device Identifier07630030825064
UDI-Public07630030825064
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K130299
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/08/2019
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 Date06/11/2023
Device Catalogue Number02.09.0214H
Device Lot Number181574
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/11/2019
Initial Report FDA Received Date02/08/2019
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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