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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 5/17MM; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/17MM; KNEE TIBIAL INSERT Back to Search Results
Model Number 02.07.0517SCF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020: lot 1904805: (b)(4) items manufactured and released on 03-jul-2019.Expiration date: 2024-06-19.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, 1 month 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-REVISION FIXED TIBIAL INSERT SC SIZE 5/17MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10604871
Report Number3005180920-2020-00671
Device Sequence Number1281917
Product Code JWH
UDI-Device Identifier07630030818578
UDI-Public07630030818578
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K103170
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Expiration Date06/19/2024
Device Model Number02.07.0517SCF
Device Catalogue Number02.07.0517SCF
Device Lot Number1904805
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/02/2020
Initial Report FDA Received Date09/30/2020
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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