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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE INSERT FLEX LEFT 14MM S4; KNEE INSERT FLEX
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MEDACTA INTERNATIONAL SA GMK-SPHERE INSERT FLEX LEFT 14MM S4; KNEE INSERT FLEX Back to Search Results
Catalog Number 02.12.0414FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 03/04/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 march 2019: lot 153757: (b)(4) items manufactured and released on 12-nov-2015.Expiration date: 2020-11-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar event reported.
 
Event or Problem Description
Revision surgery performed, 7 months after primary surgery, due to signs of infection (the pathogen is unknown).The surgeon performed a washout and liner swap and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE INSERT FLEX LEFT 14MM S4
Common Device Name
KNEE INSERT FLEX
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8473638
Report Number3005180920-2019-00219
Device Sequence Number16522729
Product Code JWH
UDI-Device Identifier07630030826610
UDI-Public07630030826610
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/02/2019
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 Date11/01/2020
Device Catalogue Number02.12.0414FL
Device Lot Number153757
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/04/2019
Initial Report FDA Received Date04/02/2019
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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