MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED, HA COATED STEM SIZE 3 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.233
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 20 october 2017 the medical affairs performed a clinical evaluation and commented as follows: subsidence of collared femoral stem 2 days after primary cementless tha.The causes for subsidence are not known; one possibility is stem undersizing and insufficient cortical contact, but bone conditions may also play a role.Only one radiographical projection is available, insufficient for full assessment.This type of problem should not be ascribed to a faulty implant.Batch review performed on 30 october 2017.Lot 171636: (b)(4) items manufactured and released on 28 june 2017.Expiration date: 2022-05-16.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
The stem had subsided.The cause of the stem subsiding is unknown.The surgeon revised the stem, head and liner.The surgery was completed successfully.

• Brand Name: AMISTEM COLLARED, HA COATED STEM SIZE 3 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6990608
• Report Number: 3005180920-2017-00629
• Device Sequence Number: 13624267
• Product Code: LZO
• UDI-Device Identifier: 07630030804588
• UDI-Public: 07630030804588
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

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: 05/16/2022
• Device Catalogue Number: 01.18.233
• Device Lot Number: 171636
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/31/2017
• 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: 67 YR