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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 3/14 MM
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM Back to Search Results
Model Number 02.12.0314FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/07/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020.Lot 165773: 30 items manufactured and released on 17-nov-2016.Expiration date: 2021-11-02.No anomalies found related to the problem.To date, 21 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in, 4 months after primary surgery, due to signs of infection and the pathogen is unknown.The surgeon performed a washout and poly-swap and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM
Common Device Name
TIBIAL INSERT FIXED SPHERE
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10800516
Report Number3005180920-2020-00776
Device Sequence Number3931462
Product Code JWH
UDI-Device Identifier07630030826412
UDI-Public07630030826412
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
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) 11/06/2020
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 Date11/02/2021
Device Model Number02.12.0314FL
Device Catalogue Number02.12.0314FL
Device Lot Number165773
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/07/2020
Initial Report FDA Received Date11/06/2020
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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