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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 / 17 MM; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 17 MM; TIBIAL INSERT FIXED Back to Search Results
Catalog Number 02.07.0317FUC
Health Effect - Clinical Code Pain (1994)
Date of Event 07/23/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018; lot 124099; 29 items manufactured and released on 18 december 2012; expiration date: 2017-10-31.No anomalies found related to the problem.To date, 15 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in complaining of pain and instability 3 years and 9 months.The surgeon upsized the poly from 17mm to 23mm.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 17 MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7804987
Report Number3005180920-2018-00625
Device Sequence Number1052675
Product Code JWH
UDI-Device Identifier07630030817359
UDI-Public07630030817359
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/22/2018
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 Date10/31/2017
Device Catalogue Number02.07.0317FUC
Device Lot Number124099
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/23/2018
Initial Report FDA Received Date08/22/2018
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;
Patient Age73 YR
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