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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L; FEMORAL COMPONENT CEMENTED
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MEDACTA INTERNATIONAL SA FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L; FEMORAL COMPONENT CEMENTED Back to Search Results
Catalog Number 02.12.0004L
Health Effect - Clinical Code No Code Available (3191)
Date of Event 08/10/2018
Type of Reportable Event Serious Injury
Event or Problem Description
On 01 august 2018 we were informed tha the surgeon planned to use the femoral component size 4r, the tibial tray size t3i4 and the tibial insert size 4 originally.After the surgery performed on (b)(6) 2018, our sales rep found that the tibial tray and tibial insert were not used as planned.Nobody found this event during the surgery.Due to this reason the revision surgery planned for (b)(6) 2018.Revision performed successfully on the (b)(6) 2018.
 
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Brand Name
FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L
Common Device Name
FEMORAL COMPONENT CEMENTED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7837108
Report Number3005180920-2018-00651
Device Sequence Number1517446
Product Code JWH
UDI-Device Identifier07630030825835
UDI-Public07630030825835
Combination Product (Y/N)N
Initial Reporter CountryJA
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 Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/31/2018
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 Date05/10/2021
Device Catalogue Number02.12.0004L
Device Lot Number162661
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/01/2018
Initial Report FDA Received Date08/31/2018
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;
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