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

Catalog Number	01.18.173
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary investigation performed by r&d project manager preliminary investigation performed on (b)(6) 2019.From the received photo of the implant it is not possible to determine the root cause of the event.A possible cause could be related, according to the medical direction, to the positioning of the stem, also related to the anatomy.Clinical evaluation performed by medical affairs department revision surgery performed 1 year and 5 months after total hip arthroplasty in a (b)(6) woman.The patient was complaining about pain.Scintigraphic image provided shows the presence of hypercaptation areas at the tip region and signs of stress shielding are visible in the x-ray suggesting distal fixation of the stem.The lateral xray view shows that this patient has a very pronounced bow of the femur and therefore it was probably difficult to find a good position for the stem, which looks misaligned on the sagittal plane.This condition may be the cause of pain, but it does not appear to be a defect of the implant.Batch review performed on (b)(6) 2019.Lot 177118: (b)(4) items manufactured and released on 23-jan-2018.Expiration date: 2023-01-15.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient felt pain and ha and difficulties to walk, the causes of this condition are unknown.The surgeon revised the stem and the head 1 year and 5 months after primary.The surgery was completed successfully.We were informed about the event on (b)(6) the revision surgery was performed on (b)(6).

• Brand Name: AMISTEM-H PROXIMAL COATING STD STEM SIZE 3
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8878380
• Report Number: 3005180920-2019-00666
• Device Sequence Number: 291110
• 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 Implanted Year: 2018
• 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): 08/09/2019

1 Device 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: 01/15/2023
• Device Catalogue Number: 01.18.173
• Device Lot Number: 177118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No