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

Model Number	01.18.151
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 march 2023: lot 2004826: (b)(4) items manufactured and released on 10-sep-2020.Expiration date: 2025-sep-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient came in for a post-op appointment and it was observed that the cemented stem had subsided slightly leaving the patient unstable.The cause of the subsided stem is unknown.About 4 months after the primary surgery, the surgeon decided to revise the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Medacta ineternational has been informed of the event on the 8th march 2023.G3.Date received by manufacturer (dd-mmm-yyyy) modified.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE 1
• Common Device Name: HIP CEMENTED STEM
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16655502
• Report Number: 3005180920-2023-00236
• Device Sequence Number: 14935962
• Product Code: LZO
• UDI-Device Identifier: 07630030804267
• UDI-Public: 07630030804267
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: 09/01/2025
• Device Model Number: 01.18.151
• Device Catalogue Number: 01.18.151
• Device Lot Number: 2004826
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2020
• 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