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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3 / 14 MM; TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3 / 14 MM; TIBIAL INSERT FIXED Back to Search Results
Model Number 02.07.0314SF
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 07/22/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 july 2021: lot 103356: (b)(4) items manufactured and released on 25-nov-2010.Expiration date: 2015-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
The patient came in reporting instability and the cause of the instability is unknown.7 years and 6 months after primary surgery the surgeon revised the tibial insert std fix s.3 / 14 mm with an insert u.C.20mm s3.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3 / 14 MM
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12257732
Report Number3005180920-2021-00670
Device Sequence Number3635415
Product Code JWH
UDI-Device Identifier07630030817304
UDI-Public07630030817304
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 Year2014
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/02/2021
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 Date10/31/2015
Device Model Number02.07.0314SF
Device Catalogue Number02.07.0314SF
Device Lot Number103356
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/22/2021
Initial Report FDA Received Date08/02/2021
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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