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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 7; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 7; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.12.027
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 05/28/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2019: lot 162216: (b)(4) items manufactured and released on 20 may 2016.Expiration date: 2021-05-09.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
About 2 years and 8 months after primary the surgeon revised the patient hip, for a stem loosening.Stem, head and liner revised successfully.The patient presented also a stem length discrepancy.
 
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Brand Name
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 7
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8731006
Report Number3005180920-2019-00511
Device Sequence Number1729821
Product Code JDI
UDI-Device Identifier07630030802089
UDI-Public07630030802089
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K082792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/25/2019
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 Date05/09/2021
Device Catalogue Number01.12.027
Device Lot Number162216
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/28/2019
Initial Report FDA Received Date06/25/2019
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 Age70 YR
Patient Weight120
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