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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 SIZE2/10 MM R; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE2/10 MM R; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.12.0210FR
Health Effect - Clinical Code Pain (1994)
Date of Event 12/21/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 january 2019: lot 148386: (b)(4) items manufactured and released on 10-jul-2015.Expiration date: 2020-05-31.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
Revision surgery performed, 3 years and 2 months after primary surgery, due to pain.The patella was resurfaced and the insert revised.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE2/10 MM R
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8256604
Report Number3005180920-2018-01116
Device Sequence Number1833116
Product Code JWH
UDI-Device Identifier07630030826146
UDI-Public07630030826146
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/17/2019
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 Date05/31/2020
Device Catalogue Number02.12.0210FR
Device Lot Number148386
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/21/2018
Initial Report FDA Received Date01/17/2019
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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