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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.12.031
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 10/18/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 november 2018.Lot 090167/t released on 23 may 2012.Expiration date: 2014-01-31.Totally, (b)(4) pieces produced.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
Revision surgery performed 6 years after primary due to stem loosening.Stem and head were revised, surgery completed successfully.
 
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Brand Name
STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8098806
Report Number3005180920-2018-00934
Device Sequence Number2035308
Product Code JDI
UDI-Device Identifier07630030802133
UDI-Public07630030802133
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K082792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/22/2018
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 Date01/31/2014
Device Catalogue Number01.12.031
Device Lot Number090167/T
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/23/2018
Initial Report FDA Received Date11/22/2018
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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