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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 6; HIP CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6; HIP CEMENTLESS STEM Back to Search Results
Catalog Number 01.12.026
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 07/15/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25-july-2019: lot 168391: (b)(4) items manufactured and released on 26-apr-2017.Expiration date: 2022-04-11.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
Revision surgery after 1 year and 7 months from the primary due to pain caused by a loose stem.The surgeon revised the stem successfully.
 
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Brand Name
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6
Common Device Name
HIP CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8877720
Report Number3005180920-2019-00667
Device Sequence Number1949212
Product Code JDI
UDI-Device Identifier07630030802072
UDI-Public07630030802072
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K082792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/09/2019
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 Date04/11/2022
Device Catalogue Number01.12.026
Device Lot Number168391
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/15/2019
Initial Report FDA Received Date08/09/2019
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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