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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 6/11 MM L; FIXED TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L; FIXED TIBIAL INSERT Back to Search Results
Model Number 02.12.0611FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/19/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 october 2020: lot 180402: (b)(4) items manufactured and released on 25-may-2018.Expiration date: 2023-05-01.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, 10 months after primary surgery, due to signs of infection and 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 6/11 MM L
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10859602
Report Number3005180920-2020-00804
Device Sequence Number14440427
Product Code JWH
UDI-Device Identifier07630030862687
UDI-Public07630030862687
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/18/2020
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 Date05/01/2023
Device Model Number02.12.0611FL
Device Catalogue Number02.12.0611FL
Device Lot Number180402
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/19/2020
Initial Report FDA Received Date11/18/2020
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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