MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM CALCAR REAMER LARGE ZIMMER HALL; HIP SURGICAL INSTRUMENT

Catalog Number	01.39.10.0033
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Femur fracture caused when the surgeon was using the large calcar reamer and the broach.The surgeon cabled the fracture completing successfully the case.The stem implanted was an amistem-p.
Additional Manufacturer Narrative
Batch review performed on 19-jun-2024 lot 2158810: (b)(4) items manufactured and released on 17-dec-2021.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.

• Brand Name: AMISTEM CALCAR REAMER LARGE ZIMMER HALL
• Common Device Name: HIP SURGICAL INSTRUMENT
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19621813
• Report Number: 3005180920-2024-00467
• Device Sequence Number: 8121949
• Product Code: LXH
• UDI-Device Identifier: 07630040763790
• UDI-Public: 07630040763790
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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 Catalogue Number: 01.39.10.0033
• Device Lot Number: 2158810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female