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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.39.206
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 07/08/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 july 2019: lot 165320: (b)(4) items manufactured and released on 12-october-2016.Expiration date: 2021-10-03.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 caused by a subsided stem.The surgeon revised the head and stem about 1 year and 6 and a half month after primary.The surgery was completed successfully.
 
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Brand Name
STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8840210
Report Number3005180920-2019-00640
Device Sequence Number205806
Product Code LZO
UDI-Device Identifier07630030885662
UDI-Public07630030885662
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K151531
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/30/2019
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 Date10/03/2021
Device Catalogue Number01.39.206
Device Lot Number165320
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/08/2019
Initial Report FDA Received Date07/30/2019
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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