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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 6/10 MM L; KNEE TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 6/10 MM L; KNEE TIBIAL INSERT FIXED Back to Search Results
Catalog Number 02.12.0610CRL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/24/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26-july-2019: lot 185599: (b)(4) items manufactured and released on 02-oct-2018.Expiration date: 2023-09-19.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 poly-swap 7 months and a half after primary.The surgery was completed successfully.We were informed about the event on (b)(4), the revision surgery has been performed on (b)(6).
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 6/10 MM L
Common Device Name
KNEE TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8909368
Report Number3005180920-2019-00690
Device Sequence Number18883393
Product Code JWH
UDI-Device Identifier07630040707756
UDI-Public07630040707756
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K181635
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/20/2019
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 Date09/19/2023
Device Catalogue Number02.12.0610CRL
Device Lot Number185599
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/22/2019
Initial Report FDA Received Date08/20/2019
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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