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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 STEM
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MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6; CEMENTLESS STEM Back to Search Results
Catalog Number 01.39.206
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 12/11/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 december 2019.Lot 163570: (b)(4) items manufactured and released on 25-jul-2016.Expiration date: 2021-07-11.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, 2 years and 9 months, complaining of pain due to a loose stem.The surgeon revised the stem and head with another company's product and revised the liner with a medacta liner.The surgery was completed successfully.
 
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Brand Name
STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6
Common Device Name
CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9563216
Report Number3005180920-2019-01127
Device Sequence Number11488604
Product Code LZO
UDI-Device Identifier07630030885662
UDI-Public07630030885662
Combination Product (Y/N)N
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 other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/08/2020
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 Date07/11/2021
Device Catalogue Number01.39.206
Device Lot Number163570
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/11/2019
Initial Report FDA Received Date01/08/2020
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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