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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA SWITZERLAND STEM COLLARED HA COATED STD STEM SIZE 5 CEMENTLESS HIP STEM

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MEDACTA SWITZERLAND STEM COLLARED HA COATED STD STEM SIZE 5 CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.235
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Joint Disorder (2373)
Event Date 01/12/2018
Event Type  Injury  
Manufacturer Narrative

Batch review performed on (b)(6) 2018: lot 166469: (b)(4) items manufactured and released on (b)(6) 2017. Expiration date: 2022-01-22. 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. Clinical evaluation performed by medical affairs director on (b)(6) 2018: hip revision surgery occurred 9 months after primary cementless total hip arthroplasty in a (b)(6) kg patient. Aseptic loosening is a possible, literature described adverse event after cementless tha and causes are often unknown. In this case, the stem failed to find initial stability, for reasons that remain unknown.

 
Event Description

Revision surgery performed after 9 months from primary due to stem loosening.

 
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Brand NameSTEM COLLARED HA COATED STD STEM SIZE 5
Type of DeviceCEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA SWITZERLAND
gewerbestrasse 3
frauenfeld, switzerland 8500
SZ 8500
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 Key7273175
MDR Text Key100158280
Report Number3005180920-2018-00045
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK121011
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 04/27/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number01.18.235
Device LOT Number166469
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/28/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/16/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/30/2017
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: 02/15/2018 Patient Sequence Number: 1
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