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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L Back to Search Results
Catalog Number 02.12.0514FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/14/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 november 2019.Lot 152438: 16 items manufactured and released on 17-jun-2019.Expiration date: 2024-05-27.No anomalies found related to the problem.To date, all items of the same lot have been already sold with one similar reported event.
 
Event or Problem Description
Second revision surgery 14 days after the first revision due to an infection and the pathogen is unknown.The surgeon performed a washout and poly-swap and the surgery was completed successfully.The first revision surgery was performed one day before the second revision due to the patient fell and his knee split open (washout and insert swap).
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9401246
Report Number3005180920-2019-01048
Device Sequence Number14010826
Product Code JWH
UDI-Device Identifier07630030826818
UDI-Public07630030826818
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/03/2019
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 Date05/27/2024
Device Catalogue Number02.12.0514FL
Device Lot Number152438
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/14/2019
Initial Report FDA Received Date12/03/2019
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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