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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 4/14MM
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MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM Back to Search Results
Catalog Number 02.07.0414SCF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/30/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 june 2018; lot 145729: (b)(4) items manufactured and released on 13 october 2014.Expiration date:2019-08-31; 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.
 
Event or Problem Description
Revision surgery after about 1 year and 8 months due to sign of infection.The pathogen is unknown.The surgeon washed out the knee and swapped the poly.
 
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Brand Name
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7637643
Report Number3005180920-2018-00461
Device Sequence Number1861608
Product Code JWH
UDI-Device Identifier07630030817878
UDI-Public07630030817878
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K103170
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/26/2018
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 Date08/31/2019
Device Catalogue Number02.07.0414SCF
Device Lot Number145729
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 05/30/2018
Initial Report FDA Received Date06/26/2018
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;
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