MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H COLLARED FEMORAL STEMS; AMISTEM COLLARED HA COATED STD STEM SIZE 7

Model Number	01.18.237
Medical Device Problem Codes	Failure to Osseointegrate (1863); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 july 2025.Lot 154538: (b)(4) items manufactured and released on 27-jan-2016.Expiration date: 2021-01-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation perfomed by medacta medical affairs manager: a revision surgery was performed 8.5 years after the primary implantation of a tha, due to stem subsidence.The available radiographic images show radiolucent lines along the entire stem, suggestive of loosening.This loosening may have caused the observed subsidence, particularly in the context of likely reduced bone quality.Additionally, cortical thickening at the distal portion of the stem and bone rarefaction at the greater trochanter are evident.Aseptic loosening is a well-documented complication in the literature, often characterized by a multifactorial or unclear etiology.Even in this case, determining the precise cause of implant failure remains challenging based on the available information.Based on the information available no definitive root cause can be established, while it is likely that the loosening contributed to the reported issue.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.
Event or Problem Description
At about 8 years 7 months after the primary, the patient came in reporting pain due to a subsided stem and the cause is unknown.The surgeon revised the stem and head with competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: AMISTEM H COLLARED FEMORAL STEMS
• Common Device Name: AMISTEM COLLARED HA COATED STD STEM SIZE 7
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22643029
• Report Number: 3005180920-2025-00708
• Device Sequence Number: 12919679
• Product Code: LZO
• UDI-Device Identifier: 07630030804625
• UDI-Public: 07630030804625
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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: 01/13/2021
• Device Model Number: 01.18.237
• Device Lot Number: 154538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2016
• 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: 79 YR
• Patient Sex: Male
• Patient Race: White