MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-H PROXIMAL COATING STD SIZE 0; HIP CEMENTLESS STEM

Catalog Number	01.18.170
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 april 2019: lot 174343: (b)(4) items manufactured and released on 05-feb-2018.Expiration date: 2023-01-25.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 clinical evaluation performed by medical affairs manager: postoperative femoral fracture, few weeks after primary cementless tha.The fracture probably happened during walking re-education period of time when a sudden movement or accidental rotation on a weakened bone due to normal femoral preparation may facilitate fracture occurrence.No reason to suspect that this event is due to a faulty device.
Event or Problem Description
On (b)(4) 2019 we were informed about a revision surgery performed on (b)(6) 2019 after 1 month and half from primary due to bone fracture.Amistem-h proximal coating std stem #0 has been replaced with quadra-c #1.

• Brand Name: STEM: AMISTEM-H PROXIMAL COATING STD SIZE 0
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8503593
• Report Number: 3005180920-2019-00259
• Device Sequence Number: 1919762
• Product Code: LZO
• UDI-Device Identifier: 07630030804359
• UDI-Public: 07630030804359
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 04/11/2019

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: 01/25/2023
• Device Catalogue Number: 01.18.170
• Device Lot Number: 174343
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/11/2019
• 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
• Patient Age: 72 YR
• Patient Weight: 74