MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 2; HIP STEM

Model Number 01.18.402

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Osseointegration (2646)

Event Date 06/23/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 24 june 2022 lot 2009272: lot 2009272: (b)(4) items manufactured and released on 11-jan-2021.Expiration date: 2025-dec-20.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: revision performed 1 year and 1 month after primary tha in a 73 year-old patient.As reported, the patient was in pain due to stem and cup loosening.During the revision both implants were removed and replaced with m-vizion implants.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided,primary stem appears to be undersized possibly due to a varus position.This condition may have prevented the stem from finding a reliable stability.A rather large cup was also used but we can not determine its role in the necessity for replacement.No reason to suspect a defective implant at the origin of this adverse event.Additional implanted components: batch review performed on 24 june 2022 on cup: versafitcup cc trio 01.26.45.0052 acetabular shell cc trio ø 52 (k103352) lot.2010282: lot 2010282: (b)(4) items manufactured and released on 01-mar-2021.Expiration date: 2025-dec-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.

Event Description

Revision surgery performed due to stem and cup loosening 1 year and 1 month after the primary surgery.No infection detected.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 2
• Type of Device: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15074525
• MDR Text Key: 296303597
• Report Number: 3005180920-2022-00546
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630040720014
• UDI-Public: 07630040720014
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K173794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.18.402
• Device Catalogue Number: 01.18.402
• Device Lot Number: 2009272
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 88 KG