MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 7; CEMENTLESS HIP STEM

Catalog Number	01.18.147
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	01/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on (b)(6) 2018: intraoperative femoral fractures occurred in a (b)(6)year old woman.These events are known possible adverse events of partial 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.Batch review performed on (b)(6) 2018: lot 153988: 38 items manufactured and released on 13 january 2016.Expiration date: 2020(b)(6).No anomalies found related to the issue.To date, 15 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
During the stem positioning an intertrochanteric fracture was generated.The surgeon completed successfully the surgery performing intraoperatively a bone cerclage.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 7
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7276208
• Report Number: 3005180920-2018-00051
• Device Sequence Number: 1847590
• Product Code: LZO
• UDI-Device Identifier: 07630030804236
• UDI-Public: 07630030804236
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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: 12/20/2020
• Device Catalogue Number: 01.18.147
• Device Lot Number: 153988
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/16/2018
• 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: 85 YR