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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 5 / 12 MM; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM; TIBIAL INSERT FIXED Back to Search Results
Catalog Number 02.07.0512FUC
Health Effect - Clinical Code Pain (1994)
Date of Event 11/08/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 december 2018: lot 102841: (b)(4) items manufactured and released on 13 october 2010.Expiration date: 2015-09-30.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 7 years and 4 months after primary surgery.The surgeon resurfaced the original patella with another company's product and performed a poly swap.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8137077
Report Number3005180920-2018-00973
Device Sequence Number262871
Product Code JWH
UDI-Device Identifier07630030818295
UDI-Public07630030818295
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 Year2011
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/06/2018
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 Date09/30/2015
Device Catalogue Number02.07.0512FUC
Device Lot Number102841
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/08/2018
Initial Report FDA Received Date12/06/2018
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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