MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 7; CEMENTLESS HIP STEM

Catalog Number	01.18.407
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 march 2019.Lot 182535: (b)(4) items manufactured and released on 29-aug-2018.Expiration date: 2023-08-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event [complaint (b)(4) (mdr 2019-00045)].Clinical evaluation performed by medical affairs manager: 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.
Event or Problem Description
Right after the primary surgery the patient continued to complain of pain.The surgeon performed a post op x-ray and found that the femur was fractured.The surgeon then, on the same day, performed a revision to replace the head, stem and then cabled the fracture.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 7
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8408124
• Report Number: 3005180920-2019-00139
• Device Sequence Number: 389786
• Product Code: LZO
• UDI-Device Identifier: 07630040720069
• UDI-Public: 07630040720069
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2019

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: 08/19/2023
• Device Catalogue Number: 01.18.407
• Device Lot Number: 182535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2019
• Initial Report FDA Received Date: 03/11/2019
• 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