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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/12MM
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/12MM Back to Search Results
Model Number 02.07.0512PSF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/15/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 may 2020: lot 179576: (b)(4) items manufactured and released on 22-mar-2018.Expiration date: 2023-03-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
Wash-out and polyswap performed 8 months after primary due to an infection.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/12MM
Common Device Name
TIBIAL INSERT PS FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
CH  6874
MDR Report Key10147231
Report Number3005180920-2020-00330
Device Sequence Number2094383
Product Code JWH
UDI-Device Identifier07630030818325
UDI-Public07630030818325
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/12/2020
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 Date03/09/2023
Device Model Number02.07.0512PSF
Device Catalogue Number02.07.0512PSF
Device Lot Number179576
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/15/2020
Initial Report FDA Received Date06/12/2020
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;
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