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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 1; CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1; CEMENTLESS STEM Back to Search Results
Model Number 01.12.021
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 11/05/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020.Lot 163264: 30 items manufactured and released on 28-sep-2016.Expiration date: 2021-09-11.No anomalies found related to the problem.To date, 29 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
Revision surgery performed after 3 years and 8 months after the primary surgery due to aseptic loosening of stem.
 
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Brand Name
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
Common Device Name
CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11036669
Report Number3005180920-2020-00945
Device Sequence Number1307522
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 Year2017
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) 12/18/2020
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 Date09/11/2021
Device Model Number01.12.021
Device Catalogue Number01.12.021
Device Lot Number163264
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/26/2020
Initial Report FDA Received Date12/18/2020
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;
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