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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 3/20MM; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 3/20MM; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.09.0320H
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/05/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 october 2018.Lot 143018: (b)(4) items manufactured and released on 11 july 2014.Expiration date: 2019-05-31.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
Revision surgery performed due to suspicion of infection about 2 years after primary surgery.Wash out and poly exchange were performed.The pathogen is unknown.The biopsies taken have not shown to grow anything.
 
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Brand Name
GMK-HINGE FIXED TIBIAL INSERT SIZE 3/20MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7938076
Report Number3005180920-2018-00751
Device Sequence Number19396999
Product Code KRO
UDI-Device Identifier07630030825156
UDI-Public07630030825156
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K130299
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/05/2018
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 Date05/31/2019
Device Catalogue Number02.09.0320H
Device Lot Number143018
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/05/2018
Initial Report FDA Received Date10/05/2018
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;
Patient Age53 YR
Patient Weight125
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