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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 #4/13 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #4/13 MM R Back to Search Results
Model Number 02.12.0413FR
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/22/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2020 lot 187260: (b)(4) items manufactured and released on 20-dec-2018.Expiration date: 2023-12-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in due to signs of infection and the pathogen is unknown.The surgeon performed an i&d and revised the poly 19 days after primary.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #4/13 MM R
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10275099
Report Number3005180920-2020-00434
Device Sequence Number16808067
Product Code JWH
UDI-Device Identifier07630030862632
UDI-Public07630030862632
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Expiration Date12/09/2023
Device Model Number02.12.0413FR
Device Catalogue Number02.12.0413FR
Device Lot Number187260
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/22/2020
Initial Report FDA Received Date07/15/2020
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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