MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS SOLID STEM STD SIZE 7; HIP CEMENTLESS STEM

Model Number	01.36.047
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
About 1 week after the primary surgery, the surgeon noted a femoral fracture on ct scans.It is unknown how the fracture occurred.Osteosynthesis was performed with nespron tape and the stem was not revised.
Additional Manufacturer Narrative
Batch review performed on 19 january 2023: lot: 2116596: (b)(4) items manufactured and released on 13-apr-2022.Expiration date: 2027-mar-28.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.Clinical evaluation performed by medacta medical manager: one week after the tha surgery, the surgeon noted a femoral fracture in the post-operative radiographic image provided.It is unknown how the fracture occurred.Osteosynthesis was performed with nespron tape and the stem was not revised.Post-operative or intra-operative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on the fact that the bone is weak after the operation or due to the bone morphology and its mechanical properties.In this case, possilbly a rather oversized stem may have contributed to the adverse event.There is no reason to suspect a malfunctioning device.

• Brand Name: SMS SOLID STEM STD SIZE 7
• Common Device Name: HIP CEMENTLESS 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: 16377687
• Report Number: 3005180920-2023-00046
• Device Sequence Number: 20369093
• Product Code: LZO
• UDI-Device Identifier: 07630030888663
• UDI-Public: 07630030888663
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 02/15/2023

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: 01.36.047
• Device Catalogue Number: 01.36.047
• Device Lot Number: 2116596
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2022
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian