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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 - 8MM; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 LM - 8MM; TIBIAL INSERT FIXED Back to Search Results
Model Number 02.18.IF3.08.LM
Health Effect - Clinical Code Pain (1994)
Date of Event 08/18/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 august 2020: lot 168006: (b)(4) items manufactured and released on 17-jan-2017.Expiration date: 2021-12-12.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 reporting pain due to laxity in the knee.1 year and 8 months after primary surgery the surgeon revised the poly implanting a thicker one and the surgery was completed successfully.
 
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Brand Name
MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 LM - 8MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10546257
Report Number3005180920-2020-00612
Device Sequence Number11521213
Product Code HSX
UDI-Device Identifier07630030895975
UDI-Public07630030895975
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 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) 09/17/2020
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 Date12/12/2021
Device Model Number02.18.IF3.08.LM
Device Catalogue Number02.18.IF3.08.LM
Device Lot Number168006
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/18/2020
Initial Report FDA Received Date09/17/2020
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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