MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.18.232
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 october 2018.Lot 180039: (b)(4) items manufactured and released on 09 june 2018.Expiration date: 2023-05-22.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 medical affairs manager on oct 19, 2018: 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
Revision surgery performed on the same day of the primary due to bone fracture discovered on the post-op xrays.No implant was removed, the fracture was cabled.

• Brand Name: STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8023977
• Report Number: 3005180920-2018-00855
• Device Sequence Number: 1756173
• Product Code: LZO
• UDI-Device Identifier: 07630030804571
• UDI-Public: 07630030804571
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: 05/22/2023
• Device Catalogue Number: 01.18.232
• Device Lot Number: 180039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/31/2018
• 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