MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.18.404
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23.April.2021: lot 2004813: (b)(4) manufactured and released on 25-sep-2020.Expiration date: 2025-09-16.No anomalies found related to the problem.To date, 56 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
2 weeks after the primary surgery the patient came in reporting pain due to a peri-prosthetic fracture of the femur and the cause of the fracture is unknown.The surgeon revised the medacta stem and head with a competitor's product and revised the medacta liner with a medacta liner.The surgeon cabled the fracture and the surgery was completed successfully.
Additional Manufacturer Narrative
After sending the initial report on (b)(6) 2021 we noticed that the date of the batch review was worng.Here below the correct version.Batch review performed on (b)(6) 2021: lot 2004813: 75 items manufactured and released on 25-sep-2020.Expiration date: 2025-09-16.No anomalies found related to the problem.To date, 56 items of the same lot have been already sold without any similar reported event.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12007037
• Report Number: 3005180920-2021-00492
• Device Sequence Number: 3426068
• Product Code: LZO
• UDI-Device Identifier: 07630040720038
• UDI-Public: 07630040720038
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 09/16/2025
• Device Catalogue Number: 01.18.404
• Device Lot Number: 2004813
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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: 85 YR