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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FIXED TIBIAL INSERT PS FIXED SIZE 3/10MM
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MEDACTA INTERNATIONAL SA GMK-PRIMARY FIXED TIBIAL INSERT PS FIXED SIZE 3/10MM Back to Search Results
Catalog Number 02.07.0310PSF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/26/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 october 2017.Lot 155635: 30 items manufactured and released on 27 november 2015.Expiration date: 2020-11-10.No anomalies found related to the problem.To date, 27 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in due to signs of infection.The pathogen is unavailable.The surgeon performed an i&d and swapped the poly.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY FIXED TIBIAL INSERT PS FIXED SIZE 3/10MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key6979318
Report Number3005180920-2017-00610
Device Sequence Number1197303
Product Code JWH
UDI-Device Identifier07630030817069
UDI-Public07630030817069
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/26/2017
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 Date11/10/2020
Device Catalogue Number02.07.0310PSF
Device Lot Number155635
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/26/2017
Initial Report FDA Received Date10/26/2017
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 Age59 YR
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