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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 7; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 7; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.39.207
Health Effect - Clinical Code Pain (1994)
Date of Event 11/16/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 december 2018.Lot 163571: (b)(4) items manufactured and released on 26 july 2016.Expiration date: 2021-07-04.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 due to the stem subsiding, 8 months and a half after primary surgery.The surgeon revised the stem and head and the surgery was completed successfully.
 
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Brand Name
MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 7
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8164770
Report Number3005180920-2018-01006
Device Sequence Number2745999
Product Code LZO
UDI-Device Identifier07630030885679
UDI-Public07630030885679
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K151531
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/14/2018
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 Date07/04/2021
Device Catalogue Number01.39.207
Device Lot Number163571
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/16/2018
Initial Report FDA Received Date12/14/2018
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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