MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3; CEMENTLESS HIP STEM

Catalog Number	01.18.403
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020.Lot 1909809: 188 items manufactured and released on 24-mar-2020.Expiration date: 15-mar-2025.No anomalies found related to the problem.To date, 166 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed due to stem migration, distally, 4 months after the primary surgery.The stem was revised but was well osseointegrated.The head was revised as well.
Additional Manufacturer Narrative
Preliminary investigation performed by medacta r&d project manager: preliminary investigation performed on 01 december 2020.The images show the stem after explant, and it appears well osseointegrated and still covered of blood.No signs of failure were noted and from the received information it was not possible to determine the root cause of the event.Clinical evaluation performed by medacta medical affairs director: femoral component revision surgery performed 4 months after cementless total hip arthroplasty in a 66 year old woman.Radiographic images provided show the presence of a subsided stem probably due to slight underusing of the component.The reason of this choice cannot be assessed not having pre-operative images.No definite cause could be determined for this adverse event.
Additional Manufacturer Narrative
Device received on 20-jan-2021 and analyzed.Visual inspection performed by r&d project manager.Looking at the stem body it is visible that the whole hydroxiapatite coating has been integrated with the bone.No scratches or signs are present on the stem surface.Looking at the stem it is not possible to determine the root cause of identified subsidence.Maybe that the stem size has been chosen improperly during the preoperative planning in respect to the bone size or an issue occured during femoral canal broach or the bone was partocolarly poore.Too much open points are identifiable, the root cause is not easy to identify.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10800344
• Report Number: 3005180920-2020-00780
• Device Sequence Number: 3931461
• Product Code: LZO
• UDI-Device Identifier: 07630040720021
• UDI-Public: 07630040720021
• 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: 2020
• 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,Followup
• Report Date (Section B): 02/18/2021

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: 03/15/2025
• Device Catalogue Number: 01.18.403
• Device Lot Number: 1909809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 10/08/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/01/2020; 02/18/2021
• 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 Age: 66 YR
• Patient Weight: 60