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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM; TIBIAL INSERT FIXED Back to Search Results
Catalog Number 02.07.0410FUC
Health Effect - Clinical Codes Pain (1994); Joint Disorder (2373)
Date of Event 06/14/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 11 july 2017.(b)(4).
 
Event or Problem Description
The patient came in complaining of pain and instability.The cause of the pain and instability is unknown.The surgeon plans to revise the poly and possible revision of the patella.The revision is scheduled for (b)(6) 2017.
 
Additional Manufacturer Narrative
Additional information received on 21 august 2017 and includes: the surgeon revised the insert as planned.The patella was not revised.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key6714007
Report Number3005180920-2017-00377
Device Sequence Number531955
Product Code JWH
UDI-Device Identifier07630030817618
UDI-Public07630030817618
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 Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/19/2017
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 Date11/30/2018
Device Catalogue Number02.07.0410FUC
Device Lot Number134902
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/14/2017
Supplement Date Received by Manufacturer06/14/2017
Initial Report FDA Received Date07/14/2017
Supplement Report FDA Received Date09/19/2017
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;
Patient Age68 YR
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