MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID SMS SOLID STEM LAT SIZE 9; CEMENTLESS HIP STEM

Model Number	01.36.069
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 october 2021: lot 2101519: (b)(4) items manufactured and released on 28-may-2021.Expiration date: 2026-05-18.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold.Clinical evaluation performed by medical affairs director.2 months after primary cementless tha the stem subsides and requires revision.According to the images supplied, a possible cause was the undersizing of the stem.We do not have enough information to understand the reasons that may have led the surgeon to undersize, if he did.The resection level chosen for this surgery was very high (most of the femoral neck was preserved), and this may lead to give a false sensation of stability even though the stem size is not yet sufficient to guarantee reliable primary stability.There is no mention of traumatic events that may have led to femoral fractures, which are not visible in the low-quality pictures supplied.The quality of the images does not allow a full evaluation of the bone quality, but it appears to be rather poor, and this may have prevented a sufficient stability by press-fit to be achieved at surgery.Visual inspection performed by r&d project manager.During the analysis some scratches were visible on the stem neck probably due to revision surgery, in any case they cannot result in stem subsidence even if present before the revision.No production defects were found, the manufacturing control measures were in compliance with the drawings.It was not possible to determine the root cause of the subject stem failure through the visual inspection.
Event or Problem Description
At 2 months after the primary surgery, the surgeon performed a revision due to stem subsidence and mobilization.

• Brand Name: STEM: SMS SOLID SMS SOLID STEM LAT SIZE 9
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12834860
• Report Number: 3005180920-2021-00889
• Device Sequence Number: 4434500
• Product Code: LZO
• UDI-Device Identifier: 07630030888816
• UDI-Public: 07630030888816
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 11/18/2021

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: 05/18/2026
• Device Model Number: 01.36.069
• Device Catalogue Number: 01.36.069
• Device Lot Number: 2101519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2021
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White