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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX #5/13 MM L
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MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX #5/13 MM L Back to Search Results
Catalog Number 02.12.0513FL
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 02/15/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 march 2018.Lot 141423: (b)(4) items manufactured and released on 08 may 2014.Expiration date: 2019-03-31.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 complaining of anterior knee pain.The surgeon believes that resurfacing the patella would alleviate the pain.The surgeon resurfaced the patella and upsized the poly from a 13mm to a 17mm poly.The surgery was completed successfully.The cause of pain is unknown.
 
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Brand Name
TIBIAL INSERT FIXED SPHERE FLEX #5/13 MM L
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7344703
Report Number3005180920-2018-00154
Device Sequence Number11268564
Product Code JWH
UDI-Device Identifier07630030862656
UDI-Public07630030862656
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/16/2018
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 Date03/31/2019
Device Catalogue Number02.12.0513FL
Device Lot Number141423
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/15/2018
Initial Report FDA Received Date03/16/2018
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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