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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 5, SHORT NECK; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5, SHORT NECK; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.12.25SN
Health Effect - Clinical Code No Code Available (3191)
Date of Event 09/26/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 october 2018: lot: 176735: (b)(4) items manufactured and released on 03 october 2017.Expiration date: 2023-02-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
19 days after primary the surgeon revised the patient hip for a stem subsidence.The reason of subsidence is unknown.Stem, head and liner swap.The surgery was completed successfully.
 
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Brand Name
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5, SHORT NECK
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8004511
Report Number3005180920-2018-00826
Device Sequence Number1190891
Product Code LZO
UDI-Device Identifier07630030802652
UDI-Public07630030802652
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/25/2018
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 Date02/11/2023
Device Catalogue Number01.12.25SN
Device Lot Number176735
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/26/2018
Initial Report FDA Received Date10/25/2018
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 Age66 YR
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