MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID COLLARED SMS COLLARED SOLID STEM STD SIZE 6; HIP FEMORAL STEM

Catalog Number	01.36.146
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Stem revision due to subsidence at about 9 months from primary surgery.The removed stem was not confirmed to have adhered to the bone.The subsidence is about 1cm.The surgery was completed successfully.The subsidence was discovered 3 months after the primary surgery, but as there was no fracture, the patient was monitored.
Additional Manufacturer Narrative
Batch review performed on 30 august 2024 lot 2218148: (b)(4) items manufactured and released on 17-jan-2023.Expiration date: 2027-12-27.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.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.During the analysis it is evaluated that the whole body of the stem is still covered with ha coating, meaning that the stem was not correctly osteointegrated with patient bone.The stem has a collar that should prevent the stem subsidence if correctly in contact with patient cortical bone.It seems that the collar was not placed in the right position during surgery.Some signs of minor damage and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem loosening reported.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the investigation does not indicate any potential manufacturing related issue.Information reported in this follow up: - pieces returned on (b)(6) 2024.- visual inspection of the devices.

• Brand Name: STEM: SMS SOLID COLLARED SMS COLLARED SOLID STEM STD SIZE 6
• Common Device Name: HIP FEMORAL 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: 20327603
• Report Number: 3005180920-2024-00758
• Device Sequence Number: 8005589
• Product Code: LZO
• UDI-Device Identifier: 07630345701732
• UDI-Public: 07630345701732
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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 Catalogue Number: 01.36.146
• Device Lot Number: 2218148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian