MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID 01.36.045 SMS SOLID STEM STD SIZE 5; HIP SOLID STEM

Model Number	01.36.045
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a subsided stem 3 months after the primary.The surgeon revised the head with a longer head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 03-january-2023.Lot 2114510: (b)(4) items manufactured and released on 09-mar-2022.Expiration date: 27-feb-2027.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: STEM: SMS SOLID 01.36.045 SMS SOLID STEM STD SIZE 5
• Common Device Name: HIP SOLID 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: 16253519
• Report Number: 3005180920-2023-00004
• Device Sequence Number: 17492766
• Product Code: LZO
• UDI-Device Identifier: 07630030888649
• UDI-Public: 07630030888649
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181693
• 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): 01/27/2023

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: 01.36.045
• Device Catalogue Number: 01.36.045
• Device Lot Number: 2114510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2022
• 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: Female