MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 5

Catalog Number	01.18.145
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs on 23 february 2018: partial hip revision surgery occurred 1 year and 3 months after primary cementless total hip arthroplasty in a young patient ((b)(6) year-old).Radiographic images provided show the presence of radiolucent lines around the proximal part of the stem both in anteroposterior and lateral projection.Signs of stress shielding are also visible suggesting a distal fixation of the stem.Aseptic loosening is a possible literature described adverse event after cementless tha and reasons are often unknown.In this case, the cause of failure cannot be determined.Batch review performed on 01 march 2018; lot 155665: (b)(4) items manufactured and released on 21 march 2016.Expiration date: 2021-03-02.No anomalies found related to the problem.To date, 33 items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by r&d product manager on 01 march 2018 based on the pictures received: the images were analyzed: the stem appears just explanted, covered with blood and showing a hydroxyapatite coating totally absorbed.From the received photo it is not possible to determine the root cause of the event.
Event or Problem Description
Patient complained of pain 1 year and 3 months after primary.Through x-rays the surgeon noticed that the stem was proximally loose.During surgery the stem was found very well fixed distally and took some time to remove.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 5
• Common Device Name: HA COATED LAT STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7344709
• Report Number: 3005180920-2018-00152
• Device Sequence Number: 11110889
• Product Code: LZO
• UDI-Device Identifier: 07630030804212
• UDI-Public: 07630030804212
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2018

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: 03/02/2021
• Device Catalogue Number: 01.18.145
• Device Lot Number: 155665
• 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: 02/14/2018
• Initial Report FDA Received Date: 03/16/2018
• 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: 40 YR
• Patient Weight: 80