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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.12.035
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 08/22/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 september 2018.Lot 135015: 14 items manufactured and released on 15 january 2014.Expiration date: 2018-11-30.No anomalies found related to the problem.To date, 13 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
About 3 years and 9 months after primary the surgeon revised the patient for stem loosening.The surgery was completed successfully.
 
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Brand Name
QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7893358
Report Number3005180920-2018-00701
Device Sequence Number1908780
Product Code JDI
UDI-Device Identifier07630030802171
UDI-Public07630030802171
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K082792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 10/17/2018
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 Date11/30/2018
Device Catalogue Number01.12.035
Device Lot Number135015
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/22/2018
Supplement Date Received by Manufacturer08/21/2018
Initial Report FDA Received Date09/20/2018
Supplement Report FDA Received Date10/17/2018
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 Age57 YR
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