MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED 01.18.235 STEM COLLARED HA COATED STD STEM SIZE 5; HIP STEM COLLARED HA COATED STD

Model Number	01.18.235
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24-oct-2022: lot 176521: (b)(4) items manufactured and released on 23-jan-2018.Expiration date: 2023-01-14.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2018.In (b)(6) 2022, the patient came into the er because of a periprosthetic fracture and the cause is unknown.The surgeon revised the stem and head to competitor components and the surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in reporting pain due to a competitor subsided stem and the cause is unknown.The surgeon revised the competitor stem and head and medacta liner.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM COLLARED 01.18.235 STEM COLLARED HA COATED STD STEM SIZE 5
• Common Device Name: HIP STEM COLLARED HA COATED STD
• 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: 15824404
• Report Number: 3005180920-2022-00841
• Device Sequence Number: 6157334
• Product Code: LZO
• UDI-Device Identifier: 07630030804601
• UDI-Public: 07630030804601
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 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): 11/18/2022

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: 01/14/2023
• Device Model Number: 01.18.235
• Device Catalogue Number: 01.18.235
• Device Lot Number: 176521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2018
• 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