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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
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R Back to Search Results
Model Number 02.12.0512FR
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 05/26/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 june 2020: lot 186081: (b)(4) items manufactured and released on 10-dec-2018.Expiration date: 2023-11-22.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 reporting pain due to a torn quadriceps tendon.1 year and 1 month after primary the surgeon repaired the tendon and revised the 12mm poly with a 14mm poly.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
TIBIAL INSERT FIXED SPHERE FLEX
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
CH  6874
MDR Report Key10193884
Report Number3005180920-2020-00352
Device Sequence Number16784359
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 Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/25/2020
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 Date11/22/2023
Device Model Number02.12.0512FR
Device Catalogue Number02.12.0512FR
Device Lot Number186081
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/26/2020
Initial Report FDA Received Date06/25/2020
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 Age76 YR
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