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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID STEM LAT SIZE 7; UNCEMENTED HIP STEM
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MEDACTA INTERNATIONAL SA STEM: SMS SOLID STEM LAT SIZE 7; UNCEMENTED HIP STEM Back to Search Results
Model Number 01.36.067
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 12/29/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05.Jan.2021: lot 1903491: (b)(4) items manufactured and released on 04-sep-2019.Expiration date: 2024-08-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
Revision surgery performed 6 months after the primary surgery due to stem subsidence.The surgeon revised the stem and the head.The surgery was completed successfully.
 
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Brand Name
STEM: SMS SOLID STEM LAT SIZE 7
Common Device Name
UNCEMENTED HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11229071
Report Number3005180920-2021-00074
Device Sequence Number19762396
Product Code LZO
UDI-Device Identifier07630030888793
UDI-Public07630030888793
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K181693
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
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) 01/26/2021
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 Date08/20/2024
Device Model Number01.36.067
Device Catalogue Number01.36.067
Device Lot Number1903491
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/29/2020
Initial Report FDA Received Date01/26/2021
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;
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