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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; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.07.0312PSF
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 04/03/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 april 2019: lot 131858: (b)(4) items manufactured and released on 04-jul-2013.Expiration date: 2018-05-31.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in, more than five years after primary surgery, complaining of instability which was caused by laxity.The surgeon revised the 12mm poly with a 17mm poly and the surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8564989
Report Number3005180920-2019-00342
Device Sequence Number14040684
Product Code JWH
UDI-Device Identifier07630030817168
UDI-Public07630030817168
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/30/2019
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 Date05/31/2018
Device Catalogue Number02.07.0312PSF
Device Lot Number131858
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/04/2019
Initial Report FDA Received Date04/30/2019
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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