MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE 2; HIP COATED STD STEM

Catalog Number	01.18.132
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 february 2024.Lot 170008: (b)(4) items manufactured and released on 15-may-2017.Expiration date: 2022-apr-20.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.Preliminary evaluation performed by r&d project manager.Looking at the picture provided, it is visible that the stem body is free of ha coating.No signs or minor damage are present on the neck of the explanted stem, meaning that the revision has been completed easily by removing the stem manually as reported in the complaint description.Based on the information available, it is not possible to identify the root cause of the stem loosening reported.Clinical evaluation performed by medical affairs department.Revision surgery was performed about 5 years and 9 months after the primary surgery due to stem loosening.From the radiographic images signs of stress shielding are visible.According to the report, the stem was able to be removed without any instruments.No radiographic history is supplied and therefore no evaluation of the initial position of the stem can be expressed.There is also no indication as to the clinical outcome during the first months and years after index surgery, which would let us understand if the mobilization took place secondarily or if this stem never found sufficient stability.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and its causes are often unknown.The reason for this failure cannot be determined.
Event or Problem Description
Revision surgery was performed about 5 years and 9 months after the primary surgery due to stem loosening.

• Brand Name: STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE 2
• Common Device Name: HIP COATED STD 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: 18965455
• Report Number: 3005180920-2024-00110
• Device Sequence Number: 8030689
• Product Code: LZO
• UDI-Device Identifier: 07630030804083
• UDI-Public: 07630030804083
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• 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): 03/22/2024

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 Expiration Date: 04/20/2022
• Device Catalogue Number: 01.18.132
• Device Lot Number: 170008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2017
• 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 Sex: Female