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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 3/23MM; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 3/23MM; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.09.0323H
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/24/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 4 november 2019.Lot 181584: 44 items manufactured and released on 06 june 2018.Expiration date: 2023-04-20.No anomalies found related to the problem.To date, 3 items of the same lot have been already sold without any similar reported events.
 
Event or Problem Description
Second revision surgery performed 4 months after the first revision surgery due to an infection and the pathogen is unknown.The surgeon performed a washout and revised the insert successfully.The first revision surgery was performed due to an infection (insert revised).
 
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Brand Name
GMK-HINGE FIXED TIBIAL INSERT SIZE 3/23MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9334343
Report Number3005180920-2019-00979
Device Sequence Number14078123
Product Code KRO
UDI-Device Identifier07630030825163
UDI-Public07630030825163
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 Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/18/2019
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 Date04/20/2023
Device Catalogue Number02.09.0323H
Device Lot Number181584
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/24/2019
Initial Report FDA Received Date11/18/2019
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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