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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 3 / 10 MM
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 10 MM Back to Search Results
Model Number 02.07.0310FUC
Health Effect - Clinical Code Pain (1994)
Date of Event 03/16/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 27 march 2020: lot 121962: (b)(4) items manufactured and released on 14 sep 2012.Expiration date: 2017-07-30.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 reporting anterior knee pain 7 years and 4 months after the primary.The surgeon revised the medacta tibial insert u.C.Fix s.3 / 10 mm with a medacta insert u.C.10mm s3 and resurfaced the patella bone.The patella was not resurfaced during the first procedure.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 10 MM
Common Device Name
TIBIAL INSERT UC FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9961451
Report Number3005180920-2020-00239
Device Sequence Number10882760
Product Code JWH
UDI-Device Identifier07630030817038
UDI-Public07630030817038
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/15/2020
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 Date07/30/2017
Device Model Number02.07.0310FUC
Device Catalogue Number02.07.0310FUC
Device Lot Number121962
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/16/2020
Initial Report FDA Received Date04/15/2020
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;
Patient Age77 YR
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