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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 2/12 MM L; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM L; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.12.0212FL
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 02/21/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 march 2019: lot 168300: (b)(4) items manufactured and released on 28-feb-2017.Expiration date: 2022-02-06.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
The patient came in complaining of pain 7 months after the primary surgery, the cause of pain is unknown.The surgeon performed a synovectomy to address the pain, the patient also presented with mid-flexion instability and the surgeon 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 2/12 MM L
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8443627
Report Number3005180920-2019-00185
Device Sequence Number2839487
Product Code JWH
UDI-Device Identifier07630030826177
UDI-Public07630030826177
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/22/2019
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? No
Operator of Device Health Professional
Device Expiration Date02/06/2022
Device Catalogue Number02.12.0212FL
Device Lot Number168300
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/21/2019
Initial Report FDA Received Date03/22/2019
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;
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