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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM L
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MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM L Back to Search Results
Catalog Number 02.12.0513FL
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 06/04/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 june 2018; lot 168321: (b)(4) items manufactured and released on 23 february 2017.Expiration date:2022-02-07; 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.Other device involved reference 02.07.0035rp (k090988) patella resurfacing size 3; lot 175543: (b)(4) items manufactured and released on 15 december 2017.Expiration date:2022-11-29; 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 surgery after about 1 month from primary due to patella dislocation in flexion.The surgeon revised the liner.
 
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Brand Name
TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM L
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7637653
Report Number3005180920-2018-00466
Device Sequence Number2195121
Product Code JWH
UDI-Device Identifier07630030862656
UDI-Public07630030862656
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/26/2018
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 Date02/07/2022
Device Catalogue Number02.12.0513FL
Device Lot Number168321
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 05/31/2018
Initial Report FDA Received Date06/26/2018
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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