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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT FIXED PS SIZE 6/12MM
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT FIXED PS SIZE 6/12MM Back to Search Results
Catalog Number 02.07.0612PSF
Health Effect - Clinical Code Pain (1994)
Date of Event 08/08/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2017.Lot 121925: (b)(4) items manufactured and released on 24 september 2012.Expiration date: 2017-08-31.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 complaining of pain.The cause of pain is unknown.The surgeon washed out the knee and swapped the poly.The surgery was completed successfully.X-rays and explants are not available.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT FIXED PS SIZE 6/12MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key6847609
Report Number3005180920-2017-00497
Device Sequence Number10780200
Product Code JWH
UDI-Device Identifier07630030818905
UDI-Public07630030818905
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 Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/07/2017
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 Date08/31/2017
Device Catalogue Number02.07.0612PSF
Device Lot Number121925
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/08/2017
Initial Report FDA Received Date09/07/2017
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 Age69 YR
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