MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 3; HIP STEM

Catalog Number	01.18.173
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director.Femoral component revision surgery in a (b)(6) year patient.In the radiographic images provided, regions of osteolysis and bone alterations are visible.No information on the time of primary surgery, patient general health or comorbidities is available.On the basis of available information, no final conclusion can be drawn.Batch review performed on 22 february 2019: lot 182814: (b)(4) items manufactured and released on 28 june 2018.Expiration date: 2023-06-25.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.
Event or Problem Description
Revision surgery performed due to stem loosening.Date of primary surgery and details about the ball head are unknown.

• Brand Name: AMISTEM-H PROXIMAL COATING STD STEM SIZE 3
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8361561
• Report Number: 3005180920-2019-00090
• Device Sequence Number: 13942870
• Product Code: LZO
• UDI-Device Identifier: 07630030804380
• UDI-Public: 07630030804380
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/22/2019

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: 06/25/2023
• Device Catalogue Number: 01.18.173
• Device Lot Number: 182814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/22/2019
• 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: 69 YR
• Patient Weight: 88