MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM COLLARED HA COATED STD STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.18.234
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	01/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs on 16 february 2018: femoral fracture occurred 3 days after primary cementless total hip arthroplasty in a 86 year old patient.No trauma was reported.Immediate postoperative fractures are known possible adverse events of total hip replacements.They may be due to the normal bone weakening caused by the intraoperative femoral preparation and favoured by bone morphology and mechanical properties.There is no reason to suspect a malfunctioning device.Batch review performed on 19 february 2018: lot 172626: (b)(4) items manufactured and released on 11 october 2017.Expiration date: 2022-10-01.No anomalies found related to the issue.To date, (b)(4)items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Three days after primary the surgeon detected a femur fracture.The cause of the fracture is unknown.The surgeon revised successfully the stem and the head with another company's product.

• Brand Name: STEM COLLARED HA COATED STD STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7281745
• Report Number: 3005180920-2018-00065
• Device Sequence Number: 16173761
• Product Code: LZO
• UDI-Device Identifier: 07630030804595
• UDI-Public: 07630030804595
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2018

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: 10/01/2022
• Device Catalogue Number: 01.18.234
• Device Lot Number: 172626
• 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: 01/26/2018
• Initial Report FDA Received Date: 02/20/2018
• 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