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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 1/12MM
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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 1/12MM Back to Search Results
Catalog Number 02.09.0112H
Medical Device Problem Code Device Issue (2379)
Health Effect - Clinical Codes Fall (1848); Pain (1994)
Date of Event 11/09/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Batch review performed on 04 december 2017.(b)(4).
 
Event or Problem Description
Three (3) months after primary the patient fell and complained knee pain.The surgeon detected that the post screw was baked out.The surgeon revised successfully the joint implanting a new thicker liner.
 
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Brand Name
GMK-HINGE FIXED TIBIAL INSERT SIZE 1/12MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7086829
Report Number3005180920-2017-00728
Device Sequence Number782449
Product Code KRO
UDI-Device Identifier07630030824982
UDI-Public07630030824982
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) 12/06/2017
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? Yes
Operator of Device Health Professional
Device Expiration Date06/30/2019
Device Catalogue Number02.09.0112H
Device Lot Number143001
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/08/2017
Initial Report FDA Received Date12/06/2017
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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