MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 6; CEMENTLESS HIP STEM

Catalog Number	01.18.176
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs on 02 february 2018 two months after primary cementless tha the femoral stem subsides significantly.The patient shows a rather peculiar anatomy and probably poor bone quality: these two factors may have led to poor initial stability and subsequent subsidence.There is no reason to suspect a faulty device.Batch review performed on 07 february 2018, lot 167935: (b)(4) items manufactured and released on 16 february 2017.Expiration date: 2022-02-08, no anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in complaining of pain 2 months after primary.The stem had subsided.The surgeon believes the cause of the subsidence is due to poor bone quality.Stem and head revised with another company's product.The surgery was completed successfully.

• Brand Name: AMISTEM-H PROXIMAL COATING STD STEM SIZE 6
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7259387
• Report Number: 3005180920-2018-00033
• Device Sequence Number: 19122297
• Product Code: LZO
• UDI-Device Identifier: 07630030804410
• UDI-Public: 07630030804410
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

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: 02/16/2017
• Device Catalogue Number: 01.18.176
• Device Lot Number: 167935
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/09/2018
• 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: 66 YR