MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MPRES 01.37.027 MPRES STEM LAT SIZE 7; HIP STEM

Model Number	01.37.027
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22-dec-2022.Lot 2106764: (b)(4) items manufactured and released on 04-nov-2021.Expiration date: 2026-10-24.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold.
Event or Problem Description
At about 3 months after the primary surgery, the patient came in reporting pain due to a subsided stem and the cause is unknown.The surgeon revised the stem and head.The surgery was completed successfully.

• Brand Name: STEM: MPRES 01.37.027 MPRES STEM LAT SIZE 7
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16205527
• Report Number: 3005180920-2022-00994
• Device Sequence Number: 20197374
• Product Code: LZO
• UDI-Device Identifier: 07630345713537
• UDI-Public: 07630345713537
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K210263
• 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: 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 Model Number: 01.37.027
• Device Catalogue Number: 01.37.027
• Device Lot Number: 2106764
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2021
• 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 Age: 65 YR
• Patient Sex: Male