MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H 01.18.131 HA COATED STD STEM SIZE 1; FEMORAL COMPONENT

Model Number	01.18.131
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 november 2021.Lot 140003: (b)(4) items manufactured and released on.18-mar-2014.Expiration date: 2019-feb-28.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event since 2017.
Event or Problem Description
The patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.At 7 years and 2 months after the primary surgery, the surgeon revised the stem and head with competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: AMISTEM H 01.18.131 HA COATED STD STEM SIZE 1
• 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: 12874308
• Report Number: 3005180920-2021-00906
• Device Sequence Number: 4353351
• Product Code: LZO
• UDI-Device Identifier: 07630030804076
• UDI-Public: 07630030804076
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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: 02/28/2019
• Device Model Number: 01.18.131
• Device Catalogue Number: 01.18.131
• Device Lot Number: 140003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2014
• 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: Other
• Patient Sex: Female