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

Catalog Number	01.18.433
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18-dec-2019: lot 188743: (b)(4) items manufactured and released on 23-jan-2019.Expiration date: 2024-jan-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2019.On (b)(6) 2019, the patient came in complaining of pain which was due to a fractured femur which was caused from falling.The surgeon cabled the fracture, and revised the stem, head, and liner.The surgery was completed successfully.Presently, on (b)(6) 2019, the patient came in complaining of pain after a physical therapy appointment, in which the therapist fractured the lesser trochanter off while stretching the leg.The surgeon replaced the medacta stem and head.The medacta cup and poly in the patient were not replaced.

• Brand Name: STEM: AMISTEM-P COLLARED STD STEM SIZE 3
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9494701
• Report Number: 3005180920-2019-01103
• Device Sequence Number: 19578662
• Product Code: LZO
• UDI-Device Identifier: 07630040720229
• UDI-Public: 07630040720229
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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: 01/09/2024
• Device Catalogue Number: 01.18.433
• Device Lot Number: 188743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/19/2019
• 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