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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 7; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 7; CEMENTLESS HIP STEM Back to Search Results
Model Number 01.39.207
Health Effect - Clinical Code Hip Fracture (2349)
Date of Event 07/22/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 july 2021: lot 2006497: (b)(4) items manufactured and released on 09-dec-2020.Expiration date: 2025-nov-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
The patient came in reporting pain due to a subsided stem and the cause of the subsided stem is a fracture of the femur (reason unknown).The surgeon revised the stem, head, and liner 2 months after the primary surgery.The surgery was completed successfully.
 
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Brand Name
STEM: 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, 6874
SZ  6874
MDR Report Key12258537
Report Number3005180920-2021-00669
Device Sequence Number14361342
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 Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/02/2021
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 Date11/26/2025
Device Model Number01.39.207
Device Catalogue Number01.39.207
Device Lot Number2006497
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/22/2021
Initial Report FDA Received Date08/02/2021
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;
Patient Age77 YR
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