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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 LM - 9MM; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 LM - 9MM; TIBIAL INSERT FIXED Back to Search Results
Model Number 02.18.IF3.09.LM
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 04/23/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 may 2021: lot 189318: (b)(4) items manufactured and released on 12-apr-2019.Expiration date: 2024-apr-01.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 an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly 2 months after primary.The surgery was completed successfully.
 
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Brand Name
MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 LM - 9MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11862773
Report Number3005180920-2021-00410
Device Sequence Number3202635
Product Code HSX
UDI-Device Identifier07630030895999
UDI-Public07630030895999
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K162084
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) 05/21/2021
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 Date04/01/2024
Device Model Number02.18.IF3.09.LM
Device Catalogue Number02.18.IF3.09.LM
Device Lot Number189318
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/23/2021
Initial Report FDA Received Date05/21/2021
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 Age80 YR
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