MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5; CEMENTLESS ANATOMICAL HIP STEM

Model Number	01.13.105L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 november 2020: lot 1903498: (b)(4) items manufactured and released on 14-aug-2019.Expiration date: 2024-07-24.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 manager: few weeks after cementless total hip arthroplasty, the patient reported pain due to stem subsidence and fracture in the calcar region.According to the report, the patient was (b)(6) year old and affected by osteoporosis.During rehabilitation period, a sudden movement on a weakened bone due to normal femoral preparation may favour the occurrence of early fracture.There is no reason to suspect a faulty device.
Event or Problem Description
4 weeks after primary thr.Patient came to the clinic complaining on pain.X-rays show subsidence of the femoral stem and fracture of the calcar.Revision of the stem performed with different manufacturer stem.It should be noted that the patient has severe osteoporosis.

• Brand Name: STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5
• Common Device Name: CEMENTLESS ANATOMICAL HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10975810
• Report Number: 3005180920-2020-00874
• Device Sequence Number: 19629863
• Product Code: LZO
• UDI-Device Identifier: 07630030803239
• UDI-Public: 07630030803239
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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: 07/24/2024
• Device Model Number: 01.13.105L
• Device Catalogue Number: 01.13.105L
• Device Lot Number: 1903498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/09/2020
• 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
• Patient Age: 80 YR
• Patient Weight: 75