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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 6/12 MM L
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM L Back to Search Results
Catalog Number 02.12.0612FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/07/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 july 2019: lot 154756: (b)(6) items manufactured and released on 15.01.2016.Expiration date: 2020-12-19.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
Revision surgery performed after 8 months from the primary due to signs of an infection (the pathogen is unknown).The surgeon performed a washout and poly-swap and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM L
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8835133
Report Number3005180920-2019-00641
Device Sequence Number19521821
Product Code JWH
UDI-Device Identifier07630030826979
UDI-Public07630030826979
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/29/2019
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 Date12/19/2020
Device Catalogue Number02.12.0612FL
Device Lot Number154756
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/08/2019
Initial Report FDA Received Date07/29/2019
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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