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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD CEMENTLESS FEMORAL STEM

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MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD CEMENTLESS FEMORAL STEM Back to Search Results
Catalog Number 01.12.023
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Unspecified Infection (1930); Joint Disorder (2373)
Event Type  Injury  
Manufacturer Narrative

On 27 october 2017, the manufacturer of the ceramic component involved in the complaint (not marketed in us) provided a document review, reporting as follows: the component properties and the microstructure as obtained from the quality documents accomplish the requirements as specified at the time of production. There are no indications of any pre-existing material defect or non-conformities regarding sterilization. Due to lack of ceramic parts further investigations cannot be done. Batch reviews performed on 30 october 2017. (b)(4). To date, all items of the same lot have been already sold without any similar reported event.

 
Event Description

Stem loosening due to infection. The revision will be done on (b)(6) 2017.

 
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Brand NameQUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD
Type of DeviceCEMENTLESS FEMORAL STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, 6874
SZ   6874
MDR Report Key6990398
MDR Text Key90674039
Report Number3005180920-2017-00634
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberK082792
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/13/2020
Device Catalogue Number01.12.023
Device LOT Number153553
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/06/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/07/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/31/2017 Patient Sequence Number: 1
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