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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 4; UNCEMENTED HIP STEM
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MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4; UNCEMENTED HIP STEM Back to Search Results
Catalog Number 01.12.024
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 05/31/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2019: lot 162563: (b)(4) items manufactured and released on 27 july 2016.Expiration date: 2021-06-29.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 performed after 2 years and 1 month due to stem loosening.The surgery was completed successfully.
 
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Brand Name
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
Common Device Name
UNCEMENTED HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8734043
Report Number3005180920-2019-00525
Device Sequence Number16787288
Product Code JDI
UDI-Device Identifier07630030802058
UDI-Public07630030802058
Combination Product (Y/N)N
Initial Reporter CountryAS
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 company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/26/2019
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 Date06/29/2021
Device Catalogue Number01.12.024
Device Lot Number162563
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/31/2019
Initial Report FDA Received Date06/26/2019
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;
Patient Age60 YR
Patient Weight110
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