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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 3/12 MM R; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R; KNEE TIBIAL INSERT Back to Search Results
Model Number 02.12.0312FR
Health Effect - Clinical Codes Pain (1994); Balance Problems (4401)
Date of Event 08/26/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 september 2020: lot 167318: (b)(4) items manufactured and released on 02-feb-2017.Expiration date: 2022-01-18.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
Anterior knee pain and instability.Patient's patella has been resurfaced and a higher liner (14 mm) has been implanted 2 years and 9 months after primary.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10579078
Report Number3005180920-2020-00634
Device Sequence Number11468805
Product Code JWH
UDI-Device Identifier07630030826382
UDI-Public07630030826382
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/24/2020
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 Date01/18/2022
Device Model Number02.12.0312FR
Device Catalogue Number02.12.0312FR
Device Lot Number167318
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/25/2020
Initial Report FDA Received Date09/24/2020
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 Weight60
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