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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 5/14 MM L; KNEE FIXED TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L; KNEE FIXED TIBIAL INSERT Back to Search Results
Model Number 02.12.0514FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/06/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31-may-2021: lot 2002760: (b)(4) items manufactured and released on 31-mar-2020.Expiration date: 2025-03-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in due to signs of infection 1 month after the primary surgery, the pathogen is unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L
Common Device Name
KNEE FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11931389
Report Number3005180920-2021-00467
Device Sequence Number4101977
Product Code JWH
UDI-Device Identifier07630030826818
UDI-Public07630030826818
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 Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/03/2021
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 Date03/29/2025
Device Model Number02.12.0514FL
Device Catalogue Number02.12.0514FL
Device Lot Number2002760
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/06/2021
Initial Report FDA Received Date06/03/2021
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 Age68 YR
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