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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/10MM; KNEE REVISION INSERT
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MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/10MM; KNEE REVISION INSERT Back to Search Results
Model Number 02.07.0510SCF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/24/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12.March.2021: lot 189545: (b)(4) items manufactured and released on 1-mar-2019.Expiration date: 2024-02-14.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
1 month after the previous revision surgery (performed due to infection, the liner was revised), the patient came in due to signs of an infection and 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-REVISION FIXED TIBIAL INSERT SC SIZE 5/10MM
Common Device Name
KNEE REVISION INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11581251
Report Number3005180920-2021-00244
Device Sequence Number4157534
Product Code JWH
UDI-Device Identifier07630030818233
UDI-Public07630030818233
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K103170
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 other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/29/2021
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 Date02/14/2024
Device Model Number02.07.0510SCF
Device Catalogue Number02.07.0510SCF
Device Lot Number189545
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/02/2021
Initial Report FDA Received Date03/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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