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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 5/12 MM R; FIXED TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R; FIXED TIBIAL INSERT Back to Search Results
Model Number 02.12.0512FR
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 09/20/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 september 2021: lot 176580: (b)(4) items manufactured and released on 09-feb-2018.Expiration date: 2023-01-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
The patient came in reporting knee pain and instability and the cause of the pain instability is unknown.1 year and 7 months after primary the surgeon revised the gmk-sphere tibial insert - flex s5r - 12mm with a gmk-sphere tibial insert - flex s5r - 17mm.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12645620
Report Number3005180920-2021-00813
Device Sequence Number16507471
Product Code JWH
UDI-Device Identifier07630030826788
UDI-Public07630030826788
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/18/2021
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 Date01/17/2023
Device Model Number02.12.0512FR
Device Catalogue Number02.12.0512FR
Device Lot Number176580
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/20/2021
Initial Report FDA Received Date10/18/2021
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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