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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 6/11 MM L
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L Back to Search Results
Model Number 02.12.0611FL
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 08/02/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 july 2021: lot 112794: (b)(4) items manufactured and released on 24-jan 2012.Expiration date: 2016-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported.
 
Event or Problem Description
4 years and 2 months after primary revision surgery for knee instability.A thicker liner was implanted successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12223757
Report Number3005180920-2021-00648
Device Sequence Number17253375
Product Code JWH
UDI-Device Identifier07630030862687
UDI-Public07630030862687
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2017
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/26/2021
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 Date09/30/2016
Device Model Number02.12.0611FL
Device Catalogue Number02.12.0611FL
Device Lot Number112794
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/12/2021
Initial Report FDA Received Date07/26/2021
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;
Patient Age53 YR
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