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

Model Number	01.13.105R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 july 2018: lot 178979: (b)(4) items manufactured and released on 15 march 2018.Expiration date: 2023-03-06.No anomalies found related to the issue.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 on jul 19, 2018: postoperative femoral fracture occurred 1 month after primary cementless total hip arthroplasty in an elderly ((b)(6)) woman.The fracture probably occurred during the walking rehabilitation period when a sudden movement on a weakened bone due to normal intraoperative femoral preparation may have caused the fracture.There is no reason to suspect a faulty device.
Event or Problem Description
On (b)(6) 2018 we were informed by the surgeon about a metaphyseal periprosthetic fracture, identified on a patient operated on (b)(6) 2018 through amis approach.Starting from (b)(6) 2018, the patient reported hip pain and, after having analyzed detailed exams (x-rays and tac images), the surgeon noticed a metaphyseal femoral fracture which caused stem loosening.The surgeon e-operated the patient on (b)(6) 2018 (through amis approach): after having easily removed the hip stem, the surgeon fixed the fracture through 3 metaphyseal bone cerclages.Finally, he implanted a quadra-r stem, also changing the femoral ball head.

• Brand Name: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 5
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7726660
• Report Number: 3005180920-2018-00565
• Device Sequence Number: 1753562
• Product Code: LZO
• UDI-Device Identifier: 07630030803246
• UDI-Public: 07630030803246
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2018

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: 03/06/2023
• Device Model Number: 01.13.105R
• Device Lot Number: 178979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/27/2018
• 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
• Patient Age: 80 YR
• Patient Weight: 60