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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 14 MM; KNEE FIXED TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 14 MM; KNEE FIXED TIBIAL INSERT Back to Search Results
Catalog Number 02.07.0214FUC
Health Effect - Clinical Code Limited Mobility Of The Implanted Joint (2671)
Date of Event 06/04/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 jun 2019: lot 132867: (b)(4) items manufactured and released on 13-sep-2013.Expiration date: 2018-07-30.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
Revision surgery performed after 4 years and 3 months after the primary due to instability caused by knee laxity.The surgeon performed a liner swap (size 14mm has been exchanged with 20 mm) and resurfaced the patella.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 14 MM
Common Device Name
KNEE FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8762587
Report Number3005180920-2019-00530
Device Sequence Number1590921
Product Code JWH
UDI-Device Identifier07630030816659
UDI-Public07630030816659
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/04/2019
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 Date07/30/2018
Device Catalogue Number02.07.0214FUC
Device Lot Number132867
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/04/2019
Initial Report FDA Received Date07/04/2019
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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