MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 0; CEMENTLESS STEM

Catalog Number	01.18.400
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 11 months from the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 182519: (b)(4) items manufactured and released on 30-aug-2018.Expiration date: 2023-07-24.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 components involved, batch review performed on (b)(6) 2023: liner: mpact 01.32.3239hct flat pe hc liner ø32/c (k103721) lot.2115600 lot 2115600: (b)(4) items manufactured and released on 15-nov-2021.Expiration date: 2026-11-01.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.Screws: mpact 01.32.6525 cancellous bone screw, flat head ø 6,5 l 25 (k103721) lot.2119514 lot 2119514: (b)(4) items manufactured and released on 16-feb-2022.Expiration date: 2027-01-31.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 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.2117181 lot 2117181: (b)(4) items manufactured and released on 28-feb-2022.Expiration date: 2027-02-14.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.Cup: mpact 01.32.148mh acetabular shell ø48 multi-hole (k132879) lot.2113915 lot 2113915: (b)(4) items manufactured and released on 10-jan-2022.Expiration date: 2026-12-19.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.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 0
• Common Device Name: 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: 17376772
• Report Number: 3005180920-2023-00581
• Device Sequence Number: 6638547
• Product Code: LZO
• UDI-Device Identifier: 07630040719995
• UDI-Public: 07630040719995
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 07/24/2023

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: 07/24/2023
• Device Catalogue Number: 01.18.400
• Device Lot Number: 182519
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2017
• 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 Sex: Female