MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE 4; HIP STEM CEMENTLESS

Model Number	01.18.244
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Periprosthetic bone fracture discovered by 1 day post-op x-rays.The fracture will be managed conservatively, with no revision surgery planned at this stage.The surgeon suspects the fracture occurred during the final stem implantation.
Additional Manufacturer Narrative
Batch review performed on 03 november 2022 lot 176527: (b)(4).Expiration date: 2023-01-22.No anomalies found related to the problem.(b)(4).Clinical evaluation performed by medical affairs department: periprosthetic bone fracture discovered 1 day after the tha surgery from the post-op radiographic images.At this stage, the surgeon decided to not doing a revision and manage the fracture conservatively.The surgeon suspects the fracture occurred during the final stem implantation.Intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.

• Brand Name: STEM: AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE 4
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15779285
• Report Number: 3005180920-2022-00867
• Device Sequence Number: 12043930
• Product Code: LZO
• UDI-Device Identifier: 07630030804694
• UDI-Public: 07630030804694
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2022

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: 01/22/2023
• Device Model Number: 01.18.244
• Device Catalogue Number: 01.18.244
• Device Lot Number: 176527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male