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

Model Number	01.18.231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years 3 months after the primary surgery, it was detected stem loosening.The patient felt abnormal feeling.No infection reported.There was no problem at the time of 1 year after the primary surgery.At the beginning the revision surgery did not seem necessary, but eventually the stem and head were replaced successfully with competitor's implants. .
Additional Manufacturer Narrative
Batch review performed on 30 november 2022.Lot 174382: (b)(4) items manufactured and released on (b)(6) 2017.Expiration date: 2022-10-09.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Preliminary investigation performed by r&d project manager: looking at the images and videos attached to the complaint it is cleraly visible that all the ha coating on the stem body has been completely absorbed by patient bone as expected.Some signs and scratches are present on the stem neck surface probably due to revision surgery.Looking at the video it is visible that the stem was mobilized inside the patient bone, meaning not correct osseointegration.It is not possible to determine the root cause of stem mobilization.Clinical evaluation performed by medical affairs manager: at about 2 years after the primary surgery, stem loosening was detected.From the images, signs of stress shielding and radiographic loosening are visible. according to report, there was no problem at the time of 1 year after the primary surgery, however radiolucent lines were already visible.It was reported that there is no infection. osseous formation around the cup and the trochanteric shoulder of the stem, as well as just below the collar may represent a reaction to external stimuli that we cannot find in the report.At the beginning a revision was not planned but since it was inevitable, the stem and head were replaced. 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.The complaint was notified with the awareness date (b)(6) 2022.The reivision was performed on (b)(6) 2022 when the complaint became a reportable event.
Additional Manufacturer Narrative
Device received on 5 january 2023: visual inspection: during the analysis it is evaluated that fragments of ha coating are present on the stem body, even if almost whole ha has been absorbed by patient bone as expected.Some sings and scratches are present on the neck part probably due to revision surgery.It is not possible to determine the root cause of reported complaint.

• Brand Name: STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 1
• Common Device Name: CEMENTLESS STEM
• 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: 15893452
• Report Number: 3005180920-2022-00906
• Device Sequence Number: 5210240
• Product Code: LZO
• UDI-Device Identifier: 07630030804564
• UDI-Public: 07630030804564
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/24/2023

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: 10/09/2022
• Device Model Number: 01.18.231
• Device Catalogue Number: 01.18.231
• Device Lot Number: 174382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2017
• 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 Sex: Female
• Patient Weight: 120 KG