MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 3; HIP STEM

Catalog Number	01.18.233
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 september 2023.Lot 178477: (b)(4) items manufactured and released on 20-mar-2018.Expiration date: 2023-03-08.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 5 years 2 months after the primary, the patient came in reporting pain due to a subsided stem and the cause of the subsided stem is unknown.The surgeon revised the stem and head and surgery was completed successfully.

• Brand Name: STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 3
• Common Device Name: HIP 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: 17929342
• Report Number: 3005180920-2023-00793
• Device Sequence Number: 12371051
• Product Code: LZO
• UDI-Device Identifier: 07630030804588
• UDI-Public: 07630030804588
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• 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): 10/13/2023

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: 03/08/2023
• Device Catalogue Number: 01.18.233
• Device Lot Number: 178477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2018
• 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: Unknown