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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 4 / 10 MM; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 4 / 10 MM; TIBIAL INSERT FIXED Back to Search Results
Catalog Number 02.07.0410SF
Health Effect - Clinical Codes Inflammation (1932); Pain (1994)
Date of Event 06/12/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2018; lot 114147: (b)(4) items manufactured and released on 19 december 2011.Expiration date: 2016-10-31; 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
Revision surgery performed due to the patient came in complaining of pain, the surgeon determined that patient had an inflamed bursa.The surgeon washed out the knee and swapped the poly.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 4 / 10 MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7677479
Report Number3005180920-2018-00497
Device Sequence Number1384425
Product Code JWH
UDI-Device Identifier07630030817663
UDI-Public07630030817663
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 Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/11/2018
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 Date10/31/2016
Device Catalogue Number02.07.0410SF
Device Lot Number114147
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/12/2018
Initial Report FDA Received Date07/11/2018
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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