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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 SIZE 4; HIP CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE 4; HIP CEMENTLESS STEM Back to Search Results
Model Number 01.12.034
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 09/16/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 december 2020: lot 152984: (b)(4) items manufactured and released on 08-oct-2015.Expiration date: 2020-09-22.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 2016.
 
Event or Problem Description
Revision surgery performed on the (b)(6) 2020, 4 and a half year after primary, due to stem loosening.Exact primary surgery date is unknown.
 
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Brand Name
STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE 4
Common Device Name
HIP CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11053943
Report Number3005180920-2020-00946
Device Sequence Number2665646
Product Code JDI
UDI-Device Identifier07630030802164
UDI-Public07630030802164
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K082792
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
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) 12/22/2020
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 Date09/22/2020
Device Model Number01.12.034
Device Catalogue Number01.12.034
Device Lot Number152984
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/26/2020
Initial Report FDA Received Date12/22/2020
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;
Patient Age65 YR
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