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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE5/11 MM L
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MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE5/11 MM L Back to Search Results
Catalog Number 02.12.0511FL
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/10/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Batch review performed on 08 may 2018 lot 170304: (b)(4) items manufactured and released on 05 april 2017.Expiration date: 2022-03-22 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.Gmk-sphere reference (b)(4); tibial tray fixed cemented size 5 l (k090988) lot 176585: (b)(4) items manufactured and released on 21 december 2017.Expiration date: 2022-12-05 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
During surgery the insert would not seat into the tibial baseplate: a secondary insert (lot 155786) was used to complete the surgery successfully.
 
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Brand Name
TIBIAL INSERT FIXED SPHERE FLEX SIZE5/11 MM L
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7494710
Report Number3005180920-2018-00308
Device Sequence Number11315418
Product Code JWH
UDI-Device Identifier07630030862649
UDI-Public07630030862649
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
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/22/2022
Device Catalogue Number02.12.0511FL
Device Lot Number170304
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 04/10/2018
Initial Report FDA Received Date05/08/2018
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 Other;
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