MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 5; CEMENTLESS HIP STEM

Catalog Number	01.18.175
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 june 2018.Lot 164519: 65 items manufactured and released on 29 september 2016.Expiration date: 2021-09-19.No anomalies found related to the problem.To date, 55 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on (b)(6) 2018.Partial hip revision surgery (stem and head) occurred 1 year after primary cementless total hip arthroplasty.Radiolucent lines are visible in gruen zone 1 and 2 suggesting proximal mobilization of the stem.Aseptic loosening is a possible, literature described adverse event after primary cementless total hip replacement and causes are often unknown.The reason of this failure cannot be determined.
Event or Problem Description
Revision due to pain and loosening of the stem 1 year after primary; radiographically a radiolucent line was found at the level of the greater trochanter.No sign infection found.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: femoral head analysis shows small metal transfer dots on the articulating surface.Regarding the stem analysis: hydroxyapatite layer is almost completely intact.This represents a sign of poor osteointegration.However, the reason of the failure cannot be determined.Clinical evaluation performed by medical affairs director on 20 june 2018 partial hip revision surgery (stem and head) occurred 1 year after primary cementless total hip arthroplasty.The radiographies supplied are not dated, so we cannot assess the onset of the pronounced retraction of bone from the implant.This phenomenon does not look like a purely mechanically-induced reaction, perhaps an osteolytic process and/or an infection also took place, but according to report infection was not detected.However, the ha layer on the stem was found substantially intact, and this is also a sign that biological activity leading to osteoointegration never started.The reason of this failure cannot be determined with the information at hand.

• Brand Name: AMISTEM-H PROXIMAL COATING STD STEM SIZE 5
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7582507
• Report Number: 3005180920-2018-00413
• Device Sequence Number: 2063444
• Product Code: LZO
• UDI-Device Identifier: 07630030804403
• UDI-Public: 07630030804403
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2018

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: 09/19/2021
• Device Catalogue Number: 01.18.175
• Device Lot Number: 164519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 07/18/2018
• 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: 77 YR
• Patient Weight: 99