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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM L
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM L Back to Search Results
Catalog Number 02.12.0514FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/10/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 december 2017.Lot 133620: (b)(4) items manufactured and released on 08 august 2013.Expiration date: 2018-06-30.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
Revision surgery performed due to signs of infection about 1 year after primary.The surgeon washed out the knee and swapped the liner.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM L
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7095273
Report Number3005180920-2017-00735
Device Sequence Number19316142
Product Code JWH
UDI-Device Identifier07630030826818
UDI-Public07630030826818
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/07/2017
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 Date06/30/2018
Device Catalogue Number02.12.0514FL
Device Lot Number133620
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 11/10/2017
Initial Report FDA Received Date12/07/2017
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 Age40 YR
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