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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 L; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.12.0312FL
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/10/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 september 2019: lot 157018: 30 items manufactured and released on 20-apr-2016.Expiration date: 2021-04-05.No anomalies found related to the problem.To date, 24 items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
On the 6 september 2019 we were informed of a revision surgery performed on the 10 september 2019 almost 2 years and 8 months after primary due to unscrewing of the insert screw.No torque limiter used during primary.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9144398
Report Number3005180920-2019-00841
Device Sequence Number16881537
Product Code JWH
UDI-Device Identifier07630030826375
UDI-Public07630030826375
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/02/2019
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? Yes
Operator of Device Health Professional
Device Expiration Date04/05/2021
Device Catalogue Number02.12.0312FL
Device Lot Number157018
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/06/2019
Initial Report FDA Received Date10/02/2019
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;
Patient Age82 YR
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