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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 2/12 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R Back to Search Results
Catalog Number 02.12.0212FR
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 may 2018; lot 143385: (b)(4) items manufactured and released on 06 june 2014.Expiration date: 2019-04-30 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
The patient came in due to signs of infection about two years after primary.The surgeon noticed a defect under the tibial implant which the surgeon packed with antibiotic beads.The surgeon performed an i & d and a poly swap.The surgery was completed successfully.Pathogen was staphylococcus.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7549096
Report Number3005180920-2018-00383
Device Sequence Number13505248
Product Code JWH
UDI-Device Identifier07630030826184
UDI-Public07630030826184
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/29/2018
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 Date04/30/2019
Device Catalogue Number02.12.0212FR
Device Lot Number143385
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 05/01/2018
Initial Report FDA Received Date05/29/2018
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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