MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.18.172
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 april 2018; lot 177116: (b)(4) items manufactured and released on 23 january 2018.Expiration date: 2023-01-14; 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 on 06 april 2018 by medical affairs: partial hip revision surgery (stem and head) occurred few weeks after primary cementless total hip arthroplasty in a (b)(6) year-old woman.Femoral stem subsided in the early postoperative weeks.Possible reasons of this event could be patient conditions and bone quality but also a slightly undersized stem may have contributed; however, the one projection available does not allow full evaluation of stem fit.The reason of this failure cannot be determined.
Event or Problem Description
The patient came in complaining of pain 9 days after the primary.The surgeon determined that the stem had subsided and revised the stem and head.The surgery was completed successfully.

• Brand Name: AMISTEM-H PROXIMAL COATING STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7402526
• Report Number: 3005180920-2018-00208
• Device Sequence Number: 19010051
• Product Code: LZO
• UDI-Device Identifier: 07630030804373
• UDI-Public: 07630030804373
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

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: 01/14/2023
• Device Catalogue Number: 01.18.172
• Device Lot Number: 177116
• 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: 03/08/2018
• Initial Report FDA Received Date: 04/06/2018
• 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: 87 YR