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

Model Number	01.18.131
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision for hip pain, at 9 years and 1 month post primary the stem was revised successfully.
Additional Manufacturer Narrative
Batch review performed on 13 october 2022: lot 130587: (b)(4) items manufactured and released on 12-apr-2013.Expiration date: 2018-02-28.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs department revision 9 years and 1 month after the index surgery in a 74 year old patient.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible.Additionally, the stem appears in pronounced varus position with evident long term signs of proximal mobilazation.We cannot tell if this is the result of post-surgery migration or the surgeon's choice: in the latter case, no explanation for this decision was supplied.The implant was revised successfully with a sms stem.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.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager during the analysis it is visible that almost proximal half of the stem body is covered with ha coating.This in unexpectable after two years of implatation, meaning that the stem was not correctly osteointegrated with patient bone.Some signs and scratches are present on the neck area probably due to revision surgery.The femoral head is connected with the stem taper.It is not possible to determine the root cause of the uncorrect stem osteointegration.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 1
• Common Device Name: HIP STEM CEMENTLESS
• 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: 15679265
• Report Number: 3005180920-2022-00803
• Device Sequence Number: 20311178
• 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: 2013
• Device Explanted Year: 2022
• 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): 01/19/2023

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: 02/28/2018
• Device Model Number: 01.18.131
• Device Catalogue Number: 01.18.131
• Device Lot Number: 130587
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2013
• 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: 74 YR
• Patient Sex: Male