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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L Back to Search Results
Catalog Number 02.12.0413FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 04/17/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 may 2018.Lot 153317: 25 items manufactured and released on 20 october 2015.Expiration date: 2020-10-04.No anomalies found related to the problem.To date, 13 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in due to signs of infection.The infection was possibly caused by a tooth abscess.The surgeon performed a washout and swapped the poly.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7518548
Report Number3005180920-2018-00330
Device Sequence Number1385280
Product Code JWH
UDI-Device Identifier07630030862618
UDI-Public07630030862618
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/16/2018
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 Date10/04/2020
Device Catalogue Number02.12.0413FL
Device Lot Number153317
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/17/2018
Initial Report FDA Received Date05/16/2018
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 Age59 YR
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