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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 3; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 3; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.39.203
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 11/15/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 december 2018: lot 166778: (b)(4) items manufactured and released on 25-jan-2017.Expiration date: 2022-01-17.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
Revision surgery performed due to stem loosening 1 year and 6 months after primary.The surgeon revised the stem and head with another company's product and the surgery was completed successfully.
 
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Brand Name
STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 3
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8164763
Report Number3005180920-2018-01002
Device Sequence Number11307440
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) 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 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 11/15/2018
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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