MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED HA COATED STEM SIZE 0 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.230
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second additional surgery underwent by the patient.In fact, the patient had already fell and fractured her femur.The surgeon cabled the fracture.No medacta product was revised at this time.Then, the patient came in for a revision of the stem.Batch review performed on 13 november 2017: lot 161423: (b)(4) items manufactured and released on 09 june 2016.Expiration date: 2021-05-22.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 by medical affairs director on 03 november 2017: revision surgery occurred 7 months after primary cementless total hip arthroplasty.According to the report, the patient fell during the walking re-education period of time and fractured the femur.During reoperation, the stem was left in place but mobilized some weeks later.No reason to suspect that this event is due to a faulty device.
Event or Problem Description
On (b)(6) 2017 the patient came in for a revision of the stem as it had become loose.The surgeon revised the stem, head and liner.The surgery was completed successfully.

• Brand Name: AMISTEM COLLARED HA COATED STEM SIZE 0 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7032789
• Report Number: 3005180920-2017-00657
• Device Sequence Number: 13484285
• Product Code: LZO
• UDI-Device Identifier: 07630030804557
• UDI-Public: 07630030804557
• 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): 11/15/2017

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: 05/22/2021
• Device Catalogue Number: 01.18.230
• Device Lot Number: 161423
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/15/2017
• 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