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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FULL-PE PS TIBIAL COMPONENT SIZE 5/12; FULL PE KNEE TIBIAL COMPONENT
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MEDACTA INTERNATIONAL SA GMK-PRIMARY FULL-PE PS TIBIAL COMPONENT SIZE 5/12; FULL PE KNEE TIBIAL COMPONENT Back to Search Results
Catalog Number 02.07.0512APPS
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 01/28/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 february 2019: lot 135910, (b)(4) items manufactured and released on 13-mar-2014.Expiration date: 2019-02-28.No anomalies found related to the problem.To date, all the items of this same lot have been already sold without any similar reported event.
 
Event or Problem Description
About 3 years after primary the surgeon revised the patient for full pe ps tibial component failure.The reason of failure is unknown.The surgery was completed successfully.Tibial tray and insert implanted successfully.
 
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Brand Name
GMK-PRIMARY FULL-PE PS TIBIAL COMPONENT SIZE 5/12
Common Device Name
FULL PE KNEE TIBIAL COMPONENT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8370497
Report Number3005180920-2019-00096
Device Sequence Number16418572
Product Code JWH
UDI-Device Identifier07630030818271
UDI-Public07630030818271
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K131310
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) 02/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Expiration Date02/28/2019
Device Catalogue Number02.07.0512APPS
Device Lot Number135910
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/28/2019
Initial Report FDA Received Date02/26/2019
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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