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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.12.20SN
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 03/14/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 april 2018; lot 090501/t: (b)(4) item manufactured and released on 24 june 2013.Expiration date: 2018-05-31 no anomalies found related to the problem.
 
Event or Problem Description
About 2 years and 2 months after primary the surgeon revised the patient for stem loosening.Stem swapped successfully.
 
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Brand Name
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7421485
Report Number3005180920-2018-00226
Device Sequence Number10901307
Product Code JDI
UDI-Device Identifier07630030802607
UDI-Public07630030802607
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K082792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/11/2018
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 Date05/31/2018
Device Catalogue Number01.12.20SN
Device Lot Number090501/T
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 03/14/2018
Initial Report FDA Received Date04/11/2018
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 Age55 YR
Patient Weight90
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