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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 6; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 6; CEMENTLESS HIP STEM Back to Search Results
Model Number 01.12.036
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 02/25/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-mar-2021.Lot 081861: (b)(4) items manufactured and released on 28-aug-2008.Expiration date: 2013-06-30.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 since 2017.
 
Event or Problem Description
Stem loosening 12 years and 2 months after the primary surgery.No revision has been performed at the moment.
 
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Brand Name
STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 6
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11560724
Report Number3005180920-2021-00232
Device Sequence Number4766673
Product Code JDI
UDI-Device Identifier07630030802188
UDI-Public07630030802188
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K082792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/24/2021
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 Date06/30/2013
Device Model Number01.12.036
Device Catalogue Number01.12.036
Device Lot Number081861
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/25/2021
Initial Report FDA Received Date03/24/2021
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 Other;
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