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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION 02.07.0417SCF FIXED TIBIAL INSERT SC SIZE 4/17MM; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-REVISION 02.07.0417SCF FIXED TIBIAL INSERT SC SIZE 4/17MM; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.07.0417SCF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/10/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 february 2019: lot 157227: (b)(4) items manufactured and released on 20-jan-2016.Expiration date: 2021-01-09.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
About 1 month and a half the surgeon revised the patient for an infection.I&d and liner swap performed successfully.
 
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Brand Name
GMK-REVISION 02.07.0417SCF FIXED TIBIAL INSERT SC SIZE 4/17MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8319906
Report Number3005180920-2019-00040
Device Sequence Number1516680
Product Code JWH
UDI-Device Identifier07630030817991
UDI-Public07630030817991
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 Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/08/2019
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 Date01/09/2021
Device Catalogue Number02.07.0417SCF
Device Lot Number157227
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/10/2019
Initial Report FDA Received Date02/08/2019
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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