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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 4, SHORT NECK; HIP CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4, SHORT NECK; HIP CEMENTLESS STEM Back to Search Results
Model Number 01.12.34SN
Health Effect - Clinical Code Pain (1994)
Date of Event 10/27/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 november 2020.Lot 177594: (b)(4) items manufactured and released on 23-jan-2018.Expiration date: 2023-01-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in reporting pain due to a loose stem.The cause of the loose stem is unknown.The surgeon revised the head and stem 2 years and 4 months after primary.The surgery was completed successfully.
 
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Brand Name
STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4, SHORT NECK
Common Device Name
HIP CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10895666
Report Number3005180920-2020-00827
Device Sequence Number11570156
Product Code LZO
UDI-Device Identifier07630030802744
UDI-Public07630030802744
Combination Product (Y/N)Y
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/24/2020
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 Health Professional
Device Expiration Date01/15/2023
Device Model Number01.12.34SN
Device Catalogue Number01.12.34SN
Device Lot Number177594
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/27/2020
Initial Report FDA Received Date11/24/2020
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 Age75 YR
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