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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 STD STEM SIZE 3; HIP CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3; HIP CEMENTLESS STEM Back to Search Results
Model Number 01.12.023
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 04/27/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Clinical evaluation: two years after primary cementless tha the stem needs to be replaced because it is too big and could never find the correct position in the femur.It must be noted that the corticals of this patient of 72 are exceptionally thick and strong.However, the cause for this revision is not a defective implant.
 
Event or Problem Description
About 2 years after primary the surgeon planned to revise the patient stem for loosening.Surgery planned on the (b)(6) 2020.
 
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Brand Name
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
Common Device Name
HIP CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874, CHE
CH  6874, CHE
MDR Report Key10091678
Report Number3005180920-2020-00292
Device Sequence Number3342613
Product Code LZO
UDI-Device Identifier07630030802041
UDI-Public07630030802041
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K082792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/27/2020
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 No Information
Device Model Number01.12.023
Device Catalogue Number01.12.023
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/27/2020
Initial Report FDA Received Date05/27/2020
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 Age72 YR
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