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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 3/14 MM R
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM R Back to Search Results
Catalog Number 02.12.0314FR
Health Effect - Clinical Code No Code Available (3191)
Date of Event 04/27/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 may 2018: lot 172815: (b)(4) items manufactured and released on 26 july 2017.Expiration date: 2022-07-10.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
Ten days after primary case (see mdr 2018-00336) the patient was revised because the femur was too in valgus and the patient knee was unstable.Only poly swap performed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM R
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7544748
Report Number3005180920-2018-00375
Device Sequence Number16187388
Product Code JWH
UDI-Device Identifier07630030826429
UDI-Public07630030826429
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 Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/17/2018
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 Date07/10/2022
Device Catalogue Number02.12.0314FR
Device Lot Number172815
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/27/2018
Initial Report FDA Received Date05/25/2018
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 Age74 YR
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