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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 /12 MM
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 /12 MM Back to Search Results
Catalog Number 02.07.0312FUC
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 03/06/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018.Lot 123066: 30 items manufactured and released on 12 november 2012.Expiration date: (b)(6)2017.No anomalies found related to the problem.To date, 29 items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
The patient was revised due to instability after two years from primary.The patient loosened over time.The surgeon revised the 12mm insert for a 17mm insert.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 /12 MM
Common Device Name
TIBIAL INSERT UC FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7398590
Report Number3005180920-2018-00203
Device Sequence Number16579663
Product Code JWH
UDI-Device Identifier07630030817137
UDI-Public07630030817137
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/05/2018
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 Date09/30/2017
Device Catalogue Number02.07.0312FUC
Device Lot Number123066
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/06/2018
Initial Report FDA Received Date04/05/2018
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;
Patient Age56 YR
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