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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
Model Number 02.07.0410FUC
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 18 may 2021: lot 113366: (b)(4) items manufactured and released on 18-jan-2012.Expiration date: 2016-11-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2017.
 
Event or Problem Description
9 years and 2 months after the primary surgery the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the tibial insert u.C.Fix s.4 / 10 mm with an insert u.C.14mm s4 to give the patient more stability.The surgery was completed successfully.
 
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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, 6874
SZ  6874
MDR Report Key11946159
Report Number3005180920-2021-00474
Device Sequence Number16415547
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 Year2012
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
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 Date11/30/2016
Device Model Number02.07.0410FUC
Device Catalogue Number02.07.0410FUC
Device Lot Number113366
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;
Patient Age75 YR
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