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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 1; HIP CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1; HIP CEMENTLESS STEM Back to Search Results
Catalog Number 01.12.021
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 12/02/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 december 2019.Lot 133180: 50 items manufactured and released on 17-sep-2013.Expiration date: 2018-08-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
Revision surgery performed almost 5 years and 11 months after primary following pain due to an aseptic loosening of the stem.During the revision, they changed the stem, the head and the liner.The surgery was completed successfully.
 
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Brand Name
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
Common Device Name
HIP CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9510757
Report Number3005180920-2019-01083
Device Sequence Number11282649
Product Code JDI
UDI-Device Identifier07630030802027
UDI-Public07630030802027
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K082792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/23/2019
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 Date08/31/2018
Device Catalogue Number01.12.021
Device Lot Number133180
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/28/2019
Initial Report FDA Received Date12/23/2019
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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