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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 S4 RM - 8MM
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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 RM - 8MM Back to Search Results
Catalog Number 02.18.IF4.08.RM
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 08/17/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 september 2018.Lot 167805: (b)(4) items manufactured and released on 9 january 2017.Expiration date: 13.12.2021.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
Revision performed due to infection after three months from primary surgery.The surgeon revised the insert.
 
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Brand Name
MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 RM - 8MM
Common Device Name
TIBIAL INSERT FIX
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7888903
Report Number3005180920-2018-00695
Device Sequence Number14134536
Product Code HSX
UDI-Device Identifier07630030896101
UDI-Public07630030896101
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K162084
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/19/2018
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 Date12/13/2021
Device Catalogue Number02.18.IF4.08.RM
Device Lot Number167805
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/20/2018
Initial Report FDA Received Date09/19/2018
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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