MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P LAT SIZE 3; FEMORAL CEMENTLESS STEM

Model Number	01.18.413
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Revision surgery for stem loosening performed 1 year after primary.The surgeon removed successfully the stem, the head and the mectaplug.
Additional Manufacturer Narrative
Batch review performed on 29 november 2021: lot 2005822: (b)(4) items manufactured and released on 05-oct-2020.Expiration date: 2025-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation: femoral component revision performed 1 year after primary total hip arthroplasty in a (b)(6) year old man.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, signs of stress shielding are visible.Aseptic loosening is a possible literature described adverse event after primary hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.
Additional Manufacturer Narrative
On january 14th 2022 we received a clarification of the description of the event.On the (b)(6) the items for analysis.Visual inspection performed by r&d project manager: during the analysis it is evaluated that almost two third of the stem body is converted with ha coating.This is unexpected considering that the stem was implanted for 1 year.It seems that the stem was not correctly osseointegrated with the patient bone.This can cause the reported stem loosening.Looking at the neck area a lot of deep signs and scratches are present, probably due to revision surgery.It is not possible to determine the root cause of reported stem loosening and stem removal.
Event or Problem Description
Revision surgery for stem loosening performed 1 year after primary.The surgeon removed successfully the stem, the head, and the sleeve.

• Brand Name: STEM: AMISTEM P LAT SIZE 3
• Common Device Name: FEMORAL 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: 13076103
• Report Number: 3005180920-2021-00997
• Device Sequence Number: 17638708
• Product Code: LZO
• UDI-Device Identifier: 07630040720120
• UDI-Public: 07630040720120
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 02/10/2022

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: 09/30/2025
• Device Model Number: 01.18.413
• Device Catalogue Number: 01.18.413
• Device Lot Number: 2005822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 87 KG