MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED 01.18.235 STEM COLLARED HA COATED STD STEM SIZE 5; HIP STEM COLLARED

Model Number	01.18.235
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 years and 7 months after the primary surgery, the patient came in reporting pain due to a fractured femur and the cause is unknown.The surgeon cabled the fracture and revised the medacta stem with a competitor stem and revised the medacta liner with a medacta liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 27-may-2022.Lot 143835: 60 items manufactured and released on 31-jul-2014.Expiration date: 2019-jun-30.No anomalies found related to the problem.To date, 59 items of the same lot have been sold without any similar reported case during the period of review.Visual inspection performed by medical affairs manager: total hip revision 7 years and 7 months after primary tha due to femoral fracture.The reason of the fracture is unknown, according to report.The fracture was cabled during revision.No reason to suspect that this event is due to a faulty device.

• Brand Name: STEM: AMISTEM COLLARED 01.18.235 STEM COLLARED HA COATED STD STEM SIZE 5
• Common Device Name: HIP STEM COLLARED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14797521
• Report Number: 3005180920-2022-00483
• Device Sequence Number: 20317119
• Product Code: LZO
• UDI-Device Identifier: 07630030804601
• UDI-Public: 07630030804601
• 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: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2022

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: 06/30/2019
• Device Model Number: 01.18.235
• Device Catalogue Number: 01.18.235
• Device Lot Number: 143835
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female