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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 4/26MM
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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/26MM Back to Search Results
Catalog Number 02.09.0426H
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/19/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018: lot 135270: 14 items manufactured and released on (b)(6)2014.Expiration date: (b)(6) 2018.No anomalies found related to the issue.To date, 2 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
This patient had a hinge revised due to a screw breakage in (b)(6) 2018.The revision was completed successfully however the screw has broken again.
 
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Brand Name
GMK-HINGE FIXED TIBIAL INSERT SIZE 4/26MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8069023
Report Number3005180920-2018-00915
Device Sequence Number14034673
Product Code KRO
UDI-Device Identifier07630030825248
UDI-Public07630030825248
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K130299
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/30/2018
Device Catalogue Number02.09.0426H
Device Lot Number135270
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/19/2018
Initial Report FDA Received Date11/14/2018
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 Other;
Patient Age61 YR
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