MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H COLLARED FEMORAL STEMS; AMISTEM COLLARED HA COATED STEM SIZE 1 LAT

Model Number	01.18.241
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 10 years and 10-months from the primary, the patient came in reporting pain due to a potted stem and the cause is unknown.The surgeon revised the stem, head and liner to medacta components.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 31 october 2025.Stem: amistem h 01.18.241 amistem collared ha coated stem size 1 lat (k121011) lot 133239: (b)(4) items manufactured and released on 24-sep-2013.Expiration date: 31-aug-2018.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation 11 years after primary cementless tha, the stem is mobilized and requires revision.There is only one radiograph supplied, which does not allow to reconstruct case history and determine when the problems started.We can see that in gruen zone 1 the stem is clearly detached from the bone on the pre-revision xray, and this lack of proximal constraint led the load transmission to take place mostly at distal level, which in turn resulted in cortical thickening and eventually pain.The canal has probably widened over time, because the stem now looks rather small (no lateral projection available - this may induce in error), but originally the sizing must have been correct as the distance between collar and resection shows that no initial subsidence took place.The root cause of the loosening is therefore probably canal widening/bone depauperation over time, or it can be ascribed to a case of idiopathic aseptic loosening.Root cause: aseptic loosening is a possible literature-described adverse event after primary hip arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: AMISTEM H COLLARED FEMORAL STEMS
• Common Device Name: AMISTEM COLLARED HA COATED STEM SIZE 1 LAT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23579772
• Report Number: 3005180920-2025-01110
• Device Sequence Number: 9259741
• Product Code: LZO
• UDI-Device Identifier: 07630030804663
• UDI-Public: 07630030804663
• Combination Product (Y/N): N
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 08/31/2018
• Device Model Number: 01.18.241
• Device Lot Number: 133239
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2013
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White