MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 3

Catalog Number	01.13.103L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 may 2018; lot 177631: (b)(4) items manufactured and released on 22 january 2018.Expiration date: 2023-01-11; 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.Clinical evaluation performed on 18 may 2018: postoperative femoral fracture occurred few weeks after primary cementless total hip arthroplasty.This event may be due to normal intraoperative bone weakening due to femoral preparation but other unknown patient characteristics may have contributed.In this case, there is no reason to suspect a malfunctioning device.
Event or Problem Description
About 15 days after surgery the surgeon revised the patient for a femur fracture.Stem, head and liner substituted successfully.

• Brand Name: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 3
• Common Device Name: CEMENTLESS ANATOMICAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7560661
• Report Number: 3005180920-2018-00389
• Device Sequence Number: 11062970
• Product Code: LZO
• UDI-Device Identifier: 07630030803192
• UDI-Public: 07630030803192
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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 Date: 01/22/2018
• Device Catalogue Number: 01.13.103L
• Device Lot Number: 177631
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention