MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.18.144
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager on november 15, 2018: hip revision surgery occurred 4 years after primary cementless total hip arthroplasty in a (b)(6) man.Pre-revision image provided shows a single mri section where limited contact between bone and implant surface is visible.Signs of stress shielding are also evident.Aseptic loosening is a possible literature described adverse event after cementless total hip replacement and causes are often unknown.The reason of this failure cannot be determined.Visual inspection performed by r&d product manager on november 21, 2018: visual inspection shows a situation in line with revision cause (distal mobilization diagnosis).Hydroxyapatite layer in the distal part has been absorbed while on the rest of the femoral stem is still visible.Batch review performed on november 22, 2018: lot 144489: (b)(4) items manufactured and released on 10 september 2014.Expiration date: 2019-07-31.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 amistem h loosening 3 years and 11 months after primary surgery.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8099786
• Report Number: 3005180920-2018-00939
• Device Sequence Number: 19341464
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2018

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: 07/31/2019
• Device Catalogue Number: 01.18.144
• Device Lot Number: 144489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/23/2018
• 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: 74 YR
• Patient Weight: 80