MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H COATED STD STEM SIZE 6; CEMENTLESS HIP STEM

Model Number	01.18.136
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27.Jan.2020: lot 187510: (b)(4) items manufactured and released on 12-dec-2018.Expiration date: 2023-11-29.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 medicla affairs manager: periprosthetic fracture occurred few weeks after cementless total hip arthroplasty in a (b)(6) year old man.During rehabilitation period, a sudden movement on a weakened bone due to normal femoral preparation may favour the occurrence of early fracture.There is no reason to suspect a faulty device.Preliminary investigation performed by r&d project manager: implant covered in biofluids.It is not possible to determine the failure root cause.
Event or Problem Description
Revision surgery performed 3 months after the primary due to periprosthetic fracture (not trauma-related).The surgeon revised the stem and the ball head.

• Brand Name: STEM: AMISTEM H COATED STD STEM SIZE 6
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9719994
• Report Number: 3005180920-2020-00074
• Device Sequence Number: 13544740
• Product Code: LZO
• UDI-Device Identifier: 07630030804120
• UDI-Public: 07630030804120
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

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: 11/29/2023
• Device Model Number: 01.18.136
• Device Catalogue Number: 01.18.136
• Device Lot Number: 187510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/18/2020
• 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: 76