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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM COLLARED HA COATED STD STEM SIZE 3; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM COLLARED HA COATED STD STEM SIZE 3; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.233
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 03/09/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 april 2018; lot 165597: (b)(4) items manufactured and released on 28 november 2016.Expiration date: 2021-11-13; no anomalies found related to the problem.To date, (b)(4)items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in complaining of pain ten days after the primary.The stem was loose.The surgeon revised the stem, head and liner successfully.
 
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Brand Name
STEM COLLARED HA COATED STD 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 Key7402532
Report Number3005180920-2018-00212
Device Sequence Number13649600
Product Code LZO
UDI-Device Identifier07630030804588
UDI-Public07630030804588
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121011
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/06/2018
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 Date11/13/2021
Device Catalogue Number01.18.233
Device Lot Number165597
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/09/2018
Initial Report FDA Received Date04/06/2018
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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