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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 4/12MM
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MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/12MM Back to Search Results
Catalog Number 02.07.0412SCF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 12/20/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27-dec-2019.Lot 189539: (b)(4) items manufactured and released on 11-mar-2019.Expiration date: 24.02.2024.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, one month after primary surgery, due to signs of infection, the pathogen is unknown.The surgeon performed a washout and revised the poly.The surgery was completed successfully.
 
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Brand Name
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/12MM
Common Device Name
FIXED TIBIAL INSERT SC
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9580029
Report Number3005180920-2019-01156
Device Sequence Number10896289
Product Code JWH
UDI-Device Identifier07630030817755
UDI-Public07630030817755
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K103170
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/13/2020
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 Date02/24/2024
Device Catalogue Number02.07.0412SCF
Device Lot Number189539
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/20/2019
Initial Report FDA Received Date01/13/2020
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 Age60 YR
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