MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.18.402
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 october 2019: lot 183737: 111 items manufactured and released on 27-sept-2018.Expiration date: 2023-09-17.No anomalies found related to the problem.To date, 101 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director.Intraoperative greater trochanter fracture in a (b)(6) woman.Intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.
Event or Problem Description
During the final stem insertion the great trochanter fractured.The surgeon decided to replace the stem and to use cerclage.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9320274
• Report Number: 3005180920-2019-00957
• Device Sequence Number: 11410172
• Product Code: LZO
• UDI-Device Identifier: 07630040720014
• UDI-Public: 07630040720014
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/14/2019

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: 09/17/2023
• Device Catalogue Number: 01.18.402
• Device Lot Number: 183737
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/14/2019
• 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