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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; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.07.0410FUC
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/25/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 october 2018.Lot 130443: (b)(4) items manufactured and released on 22 march 2013.Expiration date: 2018-02-28.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
Revision surgery performed due to signs of infection 2 years and half after primary surgery.The pathogen is unknown.The poly was revised.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8004512
Report Number3005180920-2018-00821
Device Sequence Number16526743
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 Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/25/2018
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 Date02/28/2018
Device Catalogue Number02.07.0410FUC
Device Lot Number130443
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/25/2018
Initial Report FDA Received Date10/25/2018
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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