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

Model Number	01.18.144
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 11 september 2020 lot 140773: (b)(4) items manufactured and released on 17-apr-2014.Expiration date: 2019-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: hip revision surgery performed 4 years and 9 months after primary total hip arthroplasty in an active patient.Radiographic images provided show the presence of a radiologically loosened stem and signs of stress shielding.No radiographic history is available to judge the initial position and dimension of the stem.No comments were given as to the possibility of an infection being active.Aseptic loosening is a possible, literature described adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this event cannot be determined.Preliminary analysis performed by r&d project manager: is visible that the implant is covered with biological fluids, based on the pictures received, it is not possible to determine the root cause at this phase.
Event or Problem Description
Revision surgery performed due to stem loosening after 4 years and 8 months from the primary.The patient is very active, what could be a reason for the stem loosening.The stem and the head were revised.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 4
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10654672
• Report Number: 3005180920-2020-00687
• Device Sequence Number: 3552122
• 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: 2016
• Device Explanted Year: 2020
• 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): 10/09/2020

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: 03/31/2019
• Device Model Number: 01.18.144
• Device Catalogue Number: 01.18.144
• Device Lot Number: 140773
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 72