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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM; TIBIAL INSERT FIXED Back to Search Results
Catalog Number 02.09.0214H
Health Effect - Clinical Code Hematoma (1884)
Date of Event 09/20/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 october 2017.Lot 172040: (b)(4) items manufactured and released on 19 may 2017.Expiration date: 2022-05-01.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
The patient came in presenting with a hematoma.The surgeon performed an i&d and swapped the poly.The surgery was completed successfully.
 
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Brand Name
GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key6964492
Report Number3005180920-2017-00601
Device Sequence Number16323438
Product Code KRO
UDI-Device Identifier07630030825064
UDI-Public07630030825064
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K130299
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/20/2017
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 Date05/01/2022
Device Catalogue Number02.09.0214H
Device Lot Number172040
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/20/2017
Initial Report FDA Received Date10/20/2017
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;
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