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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 4/12 MM R; KNEE POLYETHYLENE INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R; KNEE POLYETHYLENE INSERT Back to Search Results
Catalog Number 02.12.0412FR
Health Effect - Clinical Code Hematoma (1884)
Date of Event 04/23/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 may 2019: lot 189052: (b)(4) items manufactured and released on 01-mar-2019.Expiration date: 2024-02-17.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
5 days after primary the surgeon performed a revision surgery of the knee for an hematoma.The surgeon performed an i&d and poly-swap.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R
Common Device Name
KNEE POLYETHYLENE INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8631628
Report Number3005180920-2019-00399
Device Sequence Number19316752
Product Code JWH
UDI-Device Identifier07630030826580
UDI-Public07630030826580
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 Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/22/2019
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 Date02/17/2024
Device Catalogue Number02.12.0412FR
Device Lot Number189052
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/23/2019
Initial Report FDA Received Date05/22/2019
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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