MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM P 01.18.409 AMISTEM-P STD STEM SIZE 9; FEMORAL COMPONENT

Model Number	01.18.409
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 october 2021.Lot 180737: (b)(4) items manufactured and released on 05-jul-2018.Expiration date: 2023-06-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported event.
Event or Problem Description
The patient came in reporting pain due to a subsided stem and the cause of the subsided stem is unknown.About 2 months after the primary surgery, the surgeon revised the 36mm biolox delta head m with a 36mm cocr head xxl.The surgery was completed successfully.

• Brand Name: AMISTEM P 01.18.409 AMISTEM-P STD STEM SIZE 9
• Common Device Name: FEMORAL COMPONENT
• 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: 12874312
• Report Number: 3005180920-2021-00941
• Device Sequence Number: 14541201
• Product Code: LZO
• UDI-Device Identifier: 07630040720083
• UDI-Public: 07630040720083
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 11/25/2021

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: 06/24/2023
• Device Model Number: 01.18.409
• Device Catalogue Number: 01.18.409
• Device Lot Number: 180737
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2018
• 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: Other
• Patient Sex: Unknown