MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 3; CEMENTLESS HIP STEM

Catalog Number	01.18.433
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the primary hip surgery, it was observed that the patient had sustained an intra-op fracture.It is unknown at which point of the surgery the fracture occurred.The surgeon broached sequentially to the 3.A non-collared amistem was implanted but it sat lower than expected.Therefore, it was explanted (no fractures occur) and a collar stem was implanted.The hip reduced and easily dislocated.The second amistem was removed, and using a cobb, the surgeon located the fracture on the femur laterally.Finally, a competitor stem was implanted.There was no delay and the surgery was completed successfully.A consignment set was utilized.
Additional Manufacturer Narrative
Batch review performed on 18-aug-2023 lot 2248864: (b)(4) items manufactured and released on 27-apr-2023.Expiration date: 2028-04-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional item involved in the event, batch review performed on 24-aug-2023.Stem: amistem p 01.18.403 amistem-p std stem size 3 (k173794) lot.2246931 lot 2246931: (b)(4) items manufactured and released on 07-mar-2023.Expiration date: 2028-02-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• 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: 17698264
• Report Number: 3005180920-2023-00707
• Device Sequence Number: 20682546
• Product Code: LZO
• UDI-Device Identifier: 07630040720229
• UDI-Public: 07630040720229
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/07/2023

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: 01.18.433
• Device Lot Number: 2248864
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• 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 Sex: Unknown