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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 CR SIZE 2/12 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 2/12 MM R Back to Search Results
Model Number 02.12.0212CRR
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/15/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 january 2021: lot 185611: (b)(4) items manufactured and released on 25-sep-2018.Expiration date: 2023-09-10.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 an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly 10 months after primary.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 2/12 MM R
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11320658
Report Number3005180920-2021-00116
Device Sequence Number17178704
Product Code JWH
UDI-Device Identifier07630040707244
UDI-Public07630040707244
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K181635
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
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) 02/12/2021
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 Date09/10/2023
Device Model Number02.12.0212CRR
Device Catalogue Number02.12.0212CRR
Device Lot Number185611
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/15/2021
Initial Report FDA Received Date02/12/2021
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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