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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 4 / 10 MM
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM Back to Search Results
Catalog Number 02.07.0410FUC
Health Effect - Clinical Code Pain (1994)
Date of Event 02/05/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 march 2018; lot 112550: (b)(4) items manufactured and released on 25 nov 2011.Expiration date: 2016-09-30 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
The patient came in complaining of pain 6 years after primary.The cause is unknown.The surgeon swapped the insert with a new one of the same size.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM
Common Device Name
TIBIAL INSERT UC FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7319697
Report Number3005180920-2018-00120
Device Sequence Number119416
Product Code JWH
UDI-Device Identifier07630030817618
UDI-Public07630030817618
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/07/2018
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 Date09/30/2016
Device Catalogue Number02.07.0410FUC
Device Lot Number112550
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 02/05/2018
Initial Report FDA Received Date03/07/2018
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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