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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC FEMORAL STEM; FEMORAL CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA MASTERLOC FEMORAL STEM; FEMORAL CEMENTLESS STEM Back to Search Results
Catalog Number 01.39.203
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 12/04/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 january 2019: lot 166778: (b)(4) items manufactured and released on 25 january 2017.Expiration date: 2022-01-17.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.
 
Event or Problem Description
The patient came in complaining of pain caused by the stem subsiding.The surgeon revised the stem and head and the surgery was completed successfully.
 
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Brand Name
MASTERLOC FEMORAL STEM
Common Device Name
FEMORAL CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8211947
Report Number3005180920-2018-01051
Device Sequence Number16643643
Product Code LZO
UDI-Device Identifier07630030885631
UDI-Public07630030885631
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K160289
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/03/2019
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 Date01/17/2022
Device Catalogue Number01.39.203
Device Lot Number166778
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/04/2018
Initial Report FDA Received Date01/03/2019
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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