MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 01.18.144 HA COATED LAT STEM SIZE 4; HIP STEM

Model Number	01.18.144
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 november 2022.Lot 166438: (b)(4) items manufactured and released on 08-feb-2017.Expiration date: 2022-jan-30.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.Visual inspection performed by r&d project manager: during the analysis it is evaluated that all the ha coating on the stem body has been completely absorbed by patient bone as expected.Some sings and scratches are present on the neck part probably due to revision surgery.It is not possible to determine the root cause of reported aspetic loosening and stem explantation.Clinical evaluation performed by medical affaird department: revision surgery 4 years and 6 months after the primary surgery due to aseptic loosening of the stem.  radiographic image provided show the presence of radiolucent lines in gruen zones 1 and sign of stress shielding. stem, head, and liner were revised successfully. aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.
Event or Problem Description
Revision surgery performed about 4 years and 6 months after the primary surgery due to aseptic loosening of the stem.Stem, head, and liner revised successfully.

• Brand Name: STEM: AMISTEM H 01.18.144 HA COATED LAT STEM SIZE 4
• Common Device Name: HIP 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: 15885753
• Report Number: 3005180920-2022-00880
• Device Sequence Number: 4965466
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• 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): 11/30/2022

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: 01/30/2022
• Device Model Number: 01.18.144
• Device Catalogue Number: 01.18.144
• Device Lot Number: 166438
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2017
• 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 Age: 53 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White