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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 R; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.12.0514FR
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/07/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018; lot 177447: 50 items manufactured and released on 01 march 2018; expiration date: 2023-02-11.No anomalies found related to the problem.To date, 16 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in due to signs of infection 3 months after primary and the pathogen is unknown at this time.The surgeon performed a washout and poly swap.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8137070
Report Number3005180920-2018-00969
Device Sequence Number13847880
Product Code JWH
UDI-Device Identifier07630030826825
UDI-Public07630030826825
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 Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/06/2018
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 Date02/11/2023
Device Catalogue Number02.12.0514FR
Device Lot Number177447
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/07/2018
Initial Report FDA Received Date12/06/2018
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 Age54 YR
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