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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 3 / 10 MM
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 10 MM Back to Search Results
Model Number 02.07.0310FUC
Health Effect - Clinical Code No Code Available (3191)
Date of Event 12/30/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 january 2020.Lot 150899: (b)(4) items manufactured and released on 9 september 2015.Expiration date: 2020-07-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.
 
Event or Problem Description
The patient came in complaining of instability due to laxity.The surgeon revised the medacta insert u.C.10mm s3 with a medacta insert u.C.14mm s3 almost 4 years and 1 month.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 10 MM
Common Device Name
TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9641461
Report Number3005180920-2020-00008
Device Sequence Number1965403
Product Code JWH
UDI-Device Identifier07630030817038
UDI-Public07630030817038
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) 01/29/2020
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 Date07/31/2020
Device Model Number02.07.0310FUC
Device Catalogue Number02.07.0310FUC
Device Lot Number150899
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/30/2019
Initial Report FDA Received Date01/29/2020
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;
Patient Age61 YR
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