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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/14MM
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MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/14MM Back to Search Results
Catalog Number 02.07.0514SCF
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 04/09/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional information received on apr 9, 2018: the instability was due to the ligaments stretching out.No traumatic event.Batch review performed on 03 may 2018.Lot 146769: (b)(4) items manufactured and released on 29 october 2014.Expiration date: 2019-09-30 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 complaining of instability 1 year and 2 months after primary due to the ligaments stretching out.No traumatic event.The surgeon replaced the 14 mm insert with a 20 mm.The surgery was completed successfully.
 
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Brand Name
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/14MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7486991
Report Number3005180920-2018-00297
Device Sequence Number1125033
Product Code JWH
UDI-Device Identifier07630030818455
UDI-Public07630030818455
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K103170
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/04/2018
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 Date09/30/2019
Device Catalogue Number02.07.0514SCF
Device Lot Number146769
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/05/2018
Initial Report FDA Received Date05/04/2018
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 Required Intervention;
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