MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P STD STEM SIZE 3; HIP CEMENTLESS STEM

Catalog Number	01.18.403
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient undergone primary surgery on (b)(6) 2023.A first revision surgery has been performed on unknown date and for unknown causes.Ceramic liner and ball head have been explanted and revised.On (b)(6) 2024, the patient has been revised a second time due staphylococcus aureus infection.All the components have been successfully revised.
Additional Manufacturer Narrative
Implants revised in (b)(6) 2024: batch review performed on 06-may-2024: lot 2310314: (b)(4) items manufactured and released on 27-sep-2023.Expiration date: 2028-09-09.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.Additional devices involved: cup: versafitcup cc trio 01.26.45.0056 acetabular shell cc trio ø 56 (k103352) lot 2315968: (b)(4) items manufactured and released on 25-oct-2023.Expiration date: 2028-10-04.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.Ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot 2339386: (b)(4) items manufactured and released on 26-oct-2023.Expiration date: 2028-10-02.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.The liner involved in the complaint is not marketed in the usa, anyway we report the batch review.Liner: mectacer 01.29.414 ceramic liner ø 36 / f (no us) lot 2341479: (b)(4) items manufactured and released on 07-nov-2023.Expiration date: 2028-10-17.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.The refence, lot of the devices revised in during the intermediate revision surgery are not available.The date of the intermediate revision surgery is not available.They were a versafitcup liner and a mectacer ball head.Clinical evaluation performed by medacta medical affaris manager: a tha revision surgery was performed 4 months after the primary implant.The reported reason of the revision was infection caused by staphylococcus aureus.The available x-ray, conducted 1 month before revision, shows uncertain signs of bone remodeling particularly in the iliac bone and ischio-pubic branch, bone rarefaction at the greater trochanter and a possible radiolucency line in the medial aspect of the stem.Also, an initial heterotopic ossification is visible above the great trochanter and uncertain slight calcifications on the medial side.These signs are insufficient to confirm an infection diagnosis, which certainly required further investigation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.

• Brand Name: AMISTEM-P STD STEM SIZE 3
• 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: 19380011
• Report Number: 3005180920-2024-00352
• Device Sequence Number: 7689458
• Product Code: LZO
• UDI-Device Identifier: 07630040720021
• UDI-Public: 07630040720021
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 05/23/2024

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 Catalogue Number: 01.18.403
• Device Lot Number: 2310314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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: 64 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White