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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM; TIBIAL INSERT FIXED Back to Search Results
Model Number 02.07.0414SCF
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 04/05/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16.04.2021: lot 154252: (b)(4) items manufactured and released on 6-nov-2015.Expiration date: 18-10-2020.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other reported event since 2017.
 
Event or Problem Description
1 year and 3 months after the primary surgery the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the insert semiconstrained 14mm s4 with an insert semiconstrained 17mm s4 to give the patient more stability.The surgery was completed successfully.
 
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Brand Name
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11776425
Report Number3005180920-2021-00348
Device Sequence Number3437512
Product Code JWH
UDI-Device Identifier07630030817878
UDI-Public07630030817878
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K103170
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/05/2021
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 Date10/18/2020
Device Model Number02.07.0414SCF
Device Catalogue Number02.07.0414SCF
Device Lot Number154252
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/05/2021
Initial Report FDA Received Date05/05/2021
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 Hospitalization; Required Intervention;
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