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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 4/11 MM L; KNEE TIBIAL INSERT FIXED
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L; KNEE TIBIAL INSERT FIXED Back to Search Results
Catalog Number 02.12.0411FL
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 03/26/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 166493: (b)(4) items manufactured and released on (b)(6) 2016.Expiration date: 2021-11-21.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, 8 months after primary surgery, complaining of instability due to laxity.The surgeon revised the 11mm poly with a 13mm poly and the surgery was completed successfully.
 
Additional Manufacturer Narrative
The patient is female.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L
Common Device Name
KNEE TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8548593
Report Number3005180920-2019-00307
Device Sequence Number19265073
Product Code JWH
UDI-Device Identifier07630030862601
UDI-Public07630030862601
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 01/15/2021
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 Date11/21/2021
Device Catalogue Number02.12.0411FL
Device Lot Number166493
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/26/2019
Supplement Date Received by Manufacturer03/26/2019
Initial Report FDA Received Date04/25/2019
Supplement Report FDA Received Date01/15/2021
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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