MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM HA COATED LAT STEM SIZE 0; HIP CEMENTLESS STEM

Model Number	01.18.140
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 december 2021.Lot 150135: (b)(4) items manufactured and released on 03-aug-2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2017.Clinical evaluation performed by medical affairs manager.Femoral component revision surgery performed 4 years and 10 months after cementless total hip arthroplasty in a (b)(6) woman.No information concerning patient general heath status and level of activity is available.Poor quality of radiographic images provided does not allow a proper clinical evaluation.No conclusion can be drawn on the basis of elements at hand.
Event or Problem Description
At 4 years 10 months after the primary, revision surgery performed due to bad osseointegration of the stem and pain.The surgeon revised the stem and head and the surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d hip project manager: during the analysis it is visible that all ha coating on the stem body has been absorbed by patient bone as expected.Looking at the neck zone some signs and scratches are present probably due to revision surgery.It is not possible to determine the root cause of stem removal.

• Brand Name: STEM: AMISTEM HA COATED LAT STEM SIZE 0
• 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: 13074744
• Report Number: 3005180920-2021-01004
• Device Sequence Number: 11800483
• Product Code: LZO
• UDI-Device Identifier: 07630030804168
• UDI-Public: 07630030804168
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 02/09/2022

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: 06/30/2020
• Device Model Number: 01.18.140
• Device Catalogue Number: 01.18.140
• Device Lot Number: 150135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2015
• 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: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White