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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 6/17MM; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 6/17MM; TIBIAL INSERT FIXED Back to Search Results
Model Number 02.07.0617SCF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/19/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 february 2020.Lot 167097: (b)(4) items manufactured and released on 03-nov-2016.Expiration date: 2021-10-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and poly-swap 1 year and 4 months after previous surgery.The surgery was completed successfully.The patient had a pervious revision of competitor products and the surgeon implanted medacta revision, that is why the gmk rev is being reported.
 
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Brand Name
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 6/17MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874, CHE
SZ  6874, CHE
MDR Report Key9848077
Report Number3005180920-2020-00166
Device Sequence Number742976
Product Code JWH
UDI-Device Identifier07630030819155
UDI-Public07630030819155
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K103170
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/18/2020
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 Date10/19/2021
Device Model Number02.07.0617SCF
Device Catalogue Number02.07.0617SCF
Device Lot Number167097
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/19/2020
Initial Report FDA Received Date03/18/2020
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;
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