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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 4/20MM
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/20MM Back to Search Results
Model Number 02.07.0420PSF
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/04/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14-feb-2020.Lot 131348: (b)(4) items manufactured and released on 19-apr-13.Expiration date: 31.03.2018.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 since 2016.
 
Event or Problem Description
Revision surgery performed due to tension issue after 4 years and 1 month from the primary, it was supposed poly wear but not confirmed by any analysis.The surgeon replaced the inlay with a new device with the same size and thickness.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/20MM
Common Device Name
TIBIAL INSERT PS FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9793098
Report Number3005180920-2020-00123
Device Sequence Number11334899
Product Code JWH
UDI-Device Identifier07630030818066
UDI-Public07630030818066
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2020
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/05/2020
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 Date03/31/2018
Device Model Number02.07.0420PSF
Device Catalogue Number02.07.0420PSF
Device Lot Number131348
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/04/2020
Initial Report FDA Received Date03/05/2020
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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