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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 / 12 MM; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM; TIBIAL INSERT FIXED Back to Search Results
Model Number 02.07.0512FUC
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/29/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 october 2020.Lot 120151: (b)(4) manufactured and released on 15-mar-2012.Expiration date: 2017-01-31.No anomalies found related to the problem.To date, (b)(4) of the same lot have been already sold without any other similar reported event since 2016.
 
Event or Problem Description
The patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and poly-swap 7 years and 10 months after primary.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10741024
Report Number3005180920-2020-00744
Device Sequence Number16978172
Product Code JWH
UDI-Device Identifier07630030818295
UDI-Public07630030818295
Combination Product (Y/N)Y
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/27/2020
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 Date01/31/2017
Device Model Number02.07.0512FUC
Device Catalogue Number02.07.0512FUC
Device Lot Number120151
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/28/2020
Initial Report FDA Received Date10/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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