MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED STD STEM SIZE 2; HIP CEMENTLESS STEM

Catalog Number	01.18.432
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 may 2021: lot 189969: (b)(4) items manufactured and released on 02-april-2019.Expiration date: 2024-03-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: 2 years after primary cementless tha the stem is painful and gets replaced.The patient shows very narrow femoral canal with thick cortex; apparently, the stem found distal-only fixation and the proximal femor was completely shielded by the loads, which created the proximal radiolucent lines and probably gave way to stem micromotion and hence pain.We do not see evidence of a defect in the devices used.
Event or Problem Description
Revision surgery performed 1 year 10 months after the primary due to potted stem.The surgeon successfully revised stem, head and liner.

• Brand Name: AMISTEM-P COLLARED STD STEM SIZE 2
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12023024
• Report Number: 3005180920-2021-00501
• Device Sequence Number: 4899143
• Product Code: LZO
• UDI-Device Identifier: 07630040720212
• UDI-Public: 07630040720212
• 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: 2021
• 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): 06/18/2021

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: 03/18/2024
• Device Catalogue Number: 01.18.432
• Device Lot Number: 189969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/18/2021
• 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