MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 3; CEMENTLESS HIP STEM

Catalog Number	01.13.103R
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager: hip revision surgery occurred 10 days after primary cementless total hip arthroplasty in a (b)(6) year old woman.The reason for revision is a femoral fracture that probably happened due to suboptimal initial stem position.Post-primary x-ray show a slightly undersized stem in valgus position.The reason of this positioning cannot be assessed not having preoperative images.In this case there is no reason to suspect a faulty device.Batch review performed on 20 november 2018: lot 180804: (b)(4) items manufactured and released on 22-may-2018.Expiration date: 2023-05-08.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
9 days post primary, after a session of physiotherapy, the patient has felt severe pain and could not stand.X-ray revealed a periprosthetic fracture, so on the next day the patient underwent to a revision surgery: the femur was cabled with 2 cerclage wires and the stem was converted to quadra stem.The surgery was completed successfully.It was not believed that the fracture had been due to aggressive physiotherapy, but they believed that it could have been due to rapid recovery of the patient coupled with an initial valgus position and undersized stem - that might have subsided due to very early mobilization into neutral/varus position (and then became "oversized" have contributed to the fracture).

• Brand Name: STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8089816
• Report Number: 3005180920-2018-00918
• Device Sequence Number: 13772837
• Product Code: LZO
• UDI-Device Identifier: 07630030803208
• UDI-Public: 07630030803208
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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 Date: 05/08/2023
• Device Catalogue Number: 01.13.103R
• Device Lot Number: 180804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/20/2018
• 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: 74 YR
• Patient Weight: 80