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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 3; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3; CEMENTLESS HIP STEM Back to Search Results
Model Number 01.12.033
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 03/05/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 27 march 2020 lot 188485: (b)(4) items manufactured and released on 8-feb-2019.Expiration date: 2024-01-16.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 10 months after the primary surgery due to the biomechanical problem of the stem.The surgeon revised the stem, insert and the ball head.
 
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Brand Name
STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9887890
Report Number3005180920-2020-00189
Device Sequence Number16688644
Product Code JDI
UDI-Device Identifier07630030802157
UDI-Public07630030802157
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K082792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/27/2020
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 Date01/16/2024
Device Model Number01.12.033
Device Catalogue Number01.12.033
Device Lot Number188485
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/27/2020
Initial Report FDA Received Date03/27/2020
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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