MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 6

Catalog Number	01.13.106R
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 february 2019: lot 181832: (b)(4) items manufactured and released on 11-jul-2018.Expiration date: 2023-07-02.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 by medical affairs director on january 25, 2019.Femoral head revision few weeks after total hip arthroplasty.According to the report, the stem subsided but this cannot be assessed on the basis of a single x-ray.Early subsidence may be associated with insufficient primary stability achieved at the time of operation.No conclusion can be drawn on the basis of available information, but there is no reason to suspect a faulty device.
Event or Problem Description
The patient came in complaining of pain caused by a subsided stem after about 18 days from primary.The surgeon chose to leave the stem in place but revised head and added a sleeve option.

• Brand Name: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 6
• Common Device Name: CEMENTLESS ANATOMICAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8310185
• Report Number: 3005180920-2019-00024
• Device Sequence Number: 19326166
• Product Code: LZO
• UDI-Device Identifier: 07630030803260
• UDI-Public: 07630030803260
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

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: 07/02/2023
• Device Catalogue Number: 01.13.106R
• Device Lot Number: 181832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 02/06/2019
• 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: Life Threatening; Required Intervention