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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 4/12MM; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/12MM; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.07.0412PSF
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 08/27/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 september 2019 lot 150025: (b)(4) items manufactured and released on 01-oct-2015.Expiration date: 2020-07-31.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, 1 year and 8 months after primary surgery, complaining of instability and the cause of the instability is unknown.The surgeon revised the medacta insert 12mm s4 with a medacta insert 14mm s4.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/12MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9122746
Report Number3005180920-2019-00804
Device Sequence Number2810973
Product Code JWH
UDI-Device Identifier07630030817748
UDI-Public07630030817748
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/26/2019
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 Date07/31/2020
Device Catalogue Number02.07.0412PSF
Device Lot Number150025
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/27/2019
Initial Report FDA Received Date09/26/2019
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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