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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 # 5 / 12 MM; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED # 5 / 12 MM; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.07.0512FUC
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/26/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 october 2018.Lot 144982: (b)(4) items manufactured and released on 02 december 2014.Expiration date: 2022-09-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in due to signs of infection 3 years and 4 months after the primary.The pathogen is unknown.The surgeon washed out the knee and swapped the poly.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED # 5 / 12 MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8008968
Report Number3005180920-2018-00831
Device Sequence Number1552097
Product Code JWH
UDI-Device Identifier07630030818295
UDI-Public07630030818295
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 Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/26/2018
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 Date09/24/2022
Device Catalogue Number02.07.0512FUC
Device Lot Number144982
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/27/2018
Initial Report FDA Received Date10/26/2018
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;
Patient Age82 YR
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