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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; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 12 MM; TIBIAL INSERT FIXED Back to Search Results
Model Number 02.07.0312FUC
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/28/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 june 2020: lot 146172: (b)(4) items manufactured and released on 24-nov-2014.Expiration date: 2019-09-30.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 since 1-1-2016.
 
Event or Problem Description
The patient came in due to signs of infection and the pathogen is unknown.4 years and 9 months after primary surgery the surgeon performed a washout and swapped the poly.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 FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874, CHE
SZ  6874, CHE
MDR Report Key10193998
Report Number3005180920-2020-00360
Device Sequence Number2561049
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 Year2015
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/25/2020
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 No Information
Device Expiration Date09/30/2019
Device Model Number02.07.0312FUC
Device Catalogue Number02.07.0312FUC
Device Lot Number146172
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/27/2020
Initial Report FDA Received Date06/25/2020
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;
Patient Age66 YR
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