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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5
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MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5 Back to Search Results
Catalog Number 01.13.105L
Health Effect - Clinical Code Bone Fracture(s) (1870)
Date of Event 06/22/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 july 2018; lot 174988: (b)(4) items manufactured and released on 02 november 2017.Expiration date: 24.10.2022; 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
Post-op the surgeon noticed that the patient had a fracture on the femur.The surgeon went back in on the same day to revise the patient.Stem, head and bipolar head were replaced.
 
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Brand Name
MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5
Common Device Name
CEMENTLESS ANATOMICAL STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7706398
Report Number3005180920-2018-00530
Device Sequence Number19015708
Product Code LZO
UDI-Device Identifier07630030803239
UDI-Public07630030803239
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K170845
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/20/2018
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 Date10/24/2022
Device Catalogue Number01.13.105L
Device Lot Number174988
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/22/2018
Initial Report FDA Received Date07/20/2018
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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