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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/10MM
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/10MM Back to Search Results
Catalog Number 02.07.0410PSF
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 02/12/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018, lot 151560: 24 items manufactured and released on 29 october 2015.Expiration date: (b)(6) 2020.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
About 1 year and 2 month after primary the surgeon revised the patient for a knee instability.The surgeon swapped the insert from a 10mm to 14mm liner.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/10MM
Common Device Name
TIBIAL INSERT PS FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7338223
Report Number3005180920-2018-00137
Device Sequence Number1239622
Product Code JWH
UDI-Device Identifier07630030817649
UDI-Public07630030817649
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/14/2018
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 Date10/10/2020
Device Catalogue Number02.07.0410PSF
Device Lot Number151560
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 02/12/2018
Initial Report FDA Received Date03/14/2018
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 Required Intervention;
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