MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 4; HIP CEMENTLESS STEM

Model Number	01.18.134
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 november 2021: lot 178451: (b)(4) items manufactured and released on 15-mar-2018.Expiration date: 2023-03-07.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs manager: femoral component revision performed 3 years and 4 months after primary cementless total hip arthroplasty in 67 year old man.In the single radiographic projection provided, radiolucent lines are visible but stem size and position of the implants cannot be properly assessed.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.However, in this case no conclusion can be drawn on the basis of available evidence.
Event or Problem Description
Revision surgery performed 3 years 4 months after the primary due to stem loosening.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d hip project manager: during the analysis it is evaluated that almost all ha coating on the stem body has been absorbed by patient bone as expected.There are some ha residuals on the proximal part of the stem close to the resection line, it seems that the stem was implanted little bit proud.On the distal part of the stem some residuals of bone are present.There are some scratches and signs on the neck surface probably due to revision surgery.It is not possible to determine the root cause of reported stem loosening.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 4
• Common Device Name: HIP CEMENTLESS 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: 12868989
• Report Number: 3005180920-2021-00899
• Device Sequence Number: 6025020
• Product Code: LZO
• UDI-Device Identifier: 07630030804106
• UDI-Public: 07630030804106
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 01/04/2022

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: 03/07/2023
• Device Model Number: 01.18.134
• Device Catalogue Number: 01.18.134
• Device Lot Number: 178451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2018
• 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: 67 YR
• Patient Sex: Male