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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 5 / 10 MM
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 10 MM Back to Search Results
Model Number 02.07.0510FUC
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/15/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 january 2020: lot 165514: (b)(4) items manufactured and released on 21-nov-2016.Expiration date: 2021-10-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any event reported.
 
Event or Problem Description
About 1 year post primary revision surgery for suspected infection.Knee washout and liner exchange performed.Infection not confirmed after revision.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 10 MM
Common Device Name
TIBIAL INSERT UC FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9705358
Report Number3005180920-2020-00050
Device Sequence Number16981943
Product Code JWH
UDI-Device Identifier07630030818196
UDI-Public07630030818196
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/13/2020
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 Health Professional
Device Expiration Date10/23/2021
Device Model Number02.07.0510FUC
Device Catalogue Number02.07.0510FUC
Device Lot Number165514
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/15/2020
Initial Report FDA Received Date02/13/2020
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 Age73 YR
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