MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STD STEM SIZE 1; HIP CEMENTLESS STEM

Model Number	01.18.131
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12-jul-2021: lot 163825: (b)(4) items manufactured and released on 13-oct-2016.Expiration date: 2021-09-27.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event since 2017.Clinical evaluation performed by medacta medical affairs director: 3.5 years after primary cementless tha the patient feels pain and the radiographs show extended radiolucent lines, which could be compatible with infection.The tests performed, however, do not confirm any septic phenomenon, and therefore we must assume that the loosening of the prosthesis is due mainly to its distal fixation.The report mentions "poor osseointegration", but then we are informed that after two hours of strenuous work the stem would not come out and a different approach had to be undertaken with execution of a femoral flap, so perhaps it's more likely to be a case of distal potting.We can hardly identify this case as originated by a malfunction of the device, and the root cause cannot be determined with the information at hand.
Event or Problem Description
Hip revision performed after 3 years and 8 months from the primary surgery due to pain and lack of osseointegration.During the revision surgery, after the first attempts to remove the stem by anterior approach, after 2 hours without success, a posterior approach was used creating a femoral flap and the stem has been removed and replaced by a long cemented stem.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.During the analysis it is evaluated that some residuals of ha coating are present on the proximal part of the stem body, both in frontal and lateral plane.This is unexpected, meaning that the stem was not correctly osseointegrated even if implanted for 3 years.This is the cause of reported patient pain.Some scratches and signs are present on the neck part and on the taper, that is deformed, probably due to revision surgery.It is not possible to determine the root cause of incorrect osseointegration.

• Brand Name: AMISTEM H, HA COATED STD STEM SIZE 1
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12157569
• Report Number: 3005180920-2021-00567
• Device Sequence Number: 4616382
• Product Code: LZO
• UDI-Device Identifier: 07630030804076
• UDI-Public: 07630030804076
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093944
• 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): 10/07/2021

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: 09/27/2021
• Device Model Number: 01.18.131
• Device Catalogue Number: 01.18.131
• Device Lot Number: 163825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 10/07/2021
• 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: 62 YR
• Patient Weight: 90