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

Catalog Number	01.18.403
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 september 2020: lot 1907040: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 2024-11-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
After the inserting of the femoral stem into the femoral and trying reposition, the surgeon felt abnormal feeling during moving to hyperextension.The surgeon checked ct-image and discovered the fracture of the greater trochanter.The surgeon performed the bone fixation with the k-wire.Due to this event, the surgery was prolonged about 20 minutes.Bone quality was poor.Some porosis was observed.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10689617
• Report Number: 3005180920-2020-00708
• Device Sequence Number: 3899588
• Product Code: LZO
• UDI-Device Identifier: 07630040720021
• UDI-Public: 07630040720021
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 10/16/2020

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: 11/24/2024
• Device Catalogue Number: 01.18.403
• Device Lot Number: 1907040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/16/2020
• 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: Other
• Patient Age: 71 YR