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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 6/10 MM; KNEE POLYETHYLENE INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM; KNEE POLYETHYLENE INSERT Back to Search Results
Catalog Number 02.12.0610FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 04/29/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2019: lot 180401: (b)(4) items manufactured and released on 14-may-2018.Expiration date: 2023-04-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in, 21 days after primary surgery, due to signs of infection and the pathogen is unknown.The surgeon performed an i&d and liner-swap and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM
Common Device Name
KNEE POLYETHYLENE INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8645809
Report Number3005180920-2019-00410
Device Sequence Number19269572
Product Code JWH
UDI-Device Identifier07630030826931
UDI-Public07630030826931
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 Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/28/2019
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 Date04/29/2023
Device Catalogue Number02.12.0610FL
Device Lot Number180401
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/29/2019
Initial Report FDA Received Date05/28/2019
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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