MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1; HIP STEM NON CEMENTED

Model Number	01.18.401
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 december 2022.Lot 182521: (b)(4) items manufactured and released on 18-july-2018.Expiration date: 2023-07-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 3 months after the primary, the patient came in reporting pain due to a loose stem and the cause is unknown.The surgeon revised the stem and head and the surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1
• Common Device Name: HIP STEM NON CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16204987
• Report Number: 3005180920-2022-01011
• Device Sequence Number: 17228556
• Product Code: LZO
• UDI-Device Identifier: 07630040720007
• UDI-Public: 07630040720007
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 01/19/2023

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: 07/04/2023
• Device Model Number: 01.18.401
• Device Catalogue Number: 01.18.401
• Device Lot Number: 182521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2018
• 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: Required Intervention
• Patient Sex: Male