MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 0; HIP CEMENTLESS STEM

Catalog Number	01.18.130
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 september 2023 lot 148428: (b)(4) items manufactured and released on 13-may-2015.Expiration date: 2020-03-31.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.Clinical evaluation performed by medical affairs department: a stem-head revision surgery was performed 7 year and 3 months after the first implant of a tha.The reported cause of the revision was stem loosening (amistem h).No clinical data are available about the patient.From ct images (only a few slices available), we can confirm radiological loosening at the interface bone-implant.It is difficult to determine the reason for the failure based on the information provided.However, loosening is a kind of failure often described in the literature and the cause often remains unknown.The revision surgery provided the implant of a quadra-c and a new ceramic head, and it completed successfully.Visual inspection performed by r&d project manager: looking at the stem body an opaque white film is visible on approximately half 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.Some signs of minor damage and scratches are present on the neck 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.
Event or Problem Description
At about 7 years 3 months after the primary, revision surgery due to stem loosening.Stem and head successfully revised.
Additional Manufacturer Narrative
On (b)(6) 2023, we noted an error in the initial report: the device was reported as "not available" even if the visual inspection had already been performed and reported in the form.Piece is available and was returned on (b)(6) 2023.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 0
• Common Device Name: HIP 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17974891
• Report Number: 3005180920-2023-00826
• Device Sequence Number: 11642296
• Product Code: LZO
• UDI-Device Identifier: 07630030804069
• UDI-Public: 07630030804069
• 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: 2016
• Device Explanted Year: 2023
• 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): 11/03/2023

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: 03/31/2020
• Device Catalogue Number: 01.18.130
• Device Lot Number: 148428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2015
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White