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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM
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MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM Back to Search Results
Model Number 02.07.0417SCF
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 05/11/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 may 2021: lot 162518: (b)(4) items manufactured and released on 22-aug-2016.Expiration date: 2021-07-26.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 2017.
 
Event or Problem Description
The patient came in reporting instability due to laxity and the cause of the laxity is unknown.The surgeon revised the insert semiconstrained 17mm with a 23mm one 3 years and 5 months after primary to give the patient more stability.The surgery was completed successfully.
 
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Brand Name
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11946023
Report Number3005180920-2021-00478
Device Sequence Number1086230
Product Code JWH
UDI-Device Identifier07630030817991
UDI-Public07630030817991
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K103170
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/07/2021
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 Date07/26/2021
Device Model Number02.07.0417SCF
Device Catalogue Number02.07.0417SCF
Device Lot Number162518
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/11/2021
Initial Report FDA Received Date06/07/2021
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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