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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 4/14 MM L; KNEE FIXED INLAY
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MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L; KNEE FIXED INLAY Back to Search Results
Model Number 02.12.0414FL
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Pain (1994)
Date of Event 08/31/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 september 2021.Lot 140327: (b)(4) items manufactured and released on 20-mar-2014.Expiration date: 2019-01-31.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 reporting pain and the surgeon took x-rays that revealed that the screw from the tibial insert had backed out.The surgeon removed the backed-out screw and revised the poly and tibia 4 years and 8 months after primary.The surgery was completed successfully.
 
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Brand Name
TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L
Common Device Name
KNEE FIXED INLAY
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12545489
Report Number3005180920-2021-00780
Device Sequence Number4053781
Product Code JWH
UDI-Device Identifier07630030826610
UDI-Public07630030826610
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/29/2021
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 Date01/31/2019
Device Model Number02.12.0414FL
Device Catalogue Number02.12.0414FL
Device Lot Number140327
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/31/2021
Initial Report FDA Received Date09/29/2021
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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