MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H COLLARED FEMORAL STEMS; AMISTEM H COLLARED CEMENTLESS STEM STANDARD SIZE 3

Model Number	01.18.233
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary surgery on (b)(6) 2016, patient fall on 2022, pain worsened on (b)(6) 2024.On radiography stem loosening and subsidence confirmed.On (b)(6) 2024, about 8 years after the primary surgery, the surgeon revised successfully the stem, head and liner.
Additional Manufacturer Narrative
Batch review performed on 22 december 2024: lot 156253: (b)(4) items manufactured and released on 02-march-2016.Expiration date: 2021-02-17.No anomalies found related to the problem.To date, all items of the same lot have been sold with one similar reported event during the period of review.Clinical evaluation revision surgery done 8 years after primary surgery due to loosening and subsidence of the stem.According to report the patient fell in 2022 and the pain continued until (b)(6) 2024.From radiographic image, it is visible that the stem subsided probably due to the fall and the high weight of the patient.With the information at hand there is no reason to suspect a malfunctioning device.
Additional Manufacturer Narrative
Visual inspection performed by r&d department: looking at the stem body opaque white film spots are visible on some parts of the stem length.It is not possible to identify if this film is ha or bone residual, or a combined effect.Absorption of ha from the stem body can indicate that metabolic activity was taking place and that, presumably, adequate bone contact was achieved at the time of surgery.The post-op x-ray analysis could possibly provide more insight, such as the evaluation of possible early rotational instability or initial stress-shielding.Some signs of minor damage and scratches are present on the neck, on the taper and on the collar of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem loosening reported.

• Brand Name: AMISTEM H COLLARED FEMORAL STEMS
• Common Device Name: AMISTEM H COLLARED CEMENTLESS STEM STANDARD SIZE 3
• 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: 21168800
• Report Number: 3005180920-2024-01152
• Device Sequence Number: 4251933
• Product Code: LZO
• UDI-Device Identifier: 07630030804588
• UDI-Public: 07630030804588
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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): 02/26/2025

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: 02/17/2021
• Device Model Number: 01.18.233
• Device Lot Number: 156253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2016
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Race: White