MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C 01.18.153 CEMENTED STD STEM SIZE 3 LOT. 2117753; HIP CEMENTED STEM

Model Number	01.18.153
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 october 2022.Lot 2117753: (b)(4) items manufactured and released on 25-mar-2022.Expiration date: 2027-mar-14.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 reporting pain due to a periprosthetic fracture and the cause is unknown.About 1 month and a half after the primary surgery, the surgeon revised the stem and head and the surgery was completed successfully.

• Brand Name: STEM: AMISTEM C 01.18.153 CEMENTED STD STEM SIZE 3 LOT. 2117753
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15751892
• Report Number: 3005180920-2022-00814
• Device Sequence Number: 6317549
• Product Code: LZO
• UDI-Device Identifier: 07630030804281
• UDI-Public: 07630030804281
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2022

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 Model Number: 01.18.153
• Device Catalogue Number: 01.18.153
• Device Lot Number: 2117753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2022
• Initial Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2022
• 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