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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM; TIBIAL INSERT FIXED Back to Search Results
Catalog Number 02.07.0312PSF
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 11/29/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 december 2018.Lot 160958: (b)(4) items manufactured and released on 25 may2016.Expiration date: 2021-05-11.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
About 1 year and 9 months after primary the surgeon revised successfully the 12mm insert with a 17mm one.The patient was complaining knee pain and mid flexion instability.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8199389
Report Number3005180920-2018-01037
Device Sequence Number1259502
Product Code JWH
UDI-Device Identifier07630030817168
UDI-Public07630030817168
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/27/2018
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 Date05/11/2021
Device Catalogue Number02.07.0312PSF
Device Lot Number160958
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/29/2018
Initial Report FDA Received Date12/27/2018
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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