MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMIS-K LONG SIZE 4S1 LENGTH 200MM; HIP CEMENTED STEM

Catalog Number	01.20.212
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 may 2024: lot 2201597: (b)(4) items manufactured and released on 17-june-2022.Expiration date: 2027-05-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional device involved batch review performed on 03 may 2024: ball heads: mectacer 01.29.213 biolox delta ceramic ball head 12/14 ø 40 size m 0 (k112115) lot 178808a: (b)(4) items manufactured and released on 09-aug-2023.Expiration date: 2028-07-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 4 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the stem and head.The surgery was completed successfully.

• Brand Name: STEM: AMIS-K LONG SIZE 4S1 LENGTH 200MM
• Common Device Name: HIP CEMENTED 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: 19328732
• Report Number: 3005180920-2024-00337
• Device Sequence Number: 20583921
• Product Code: LZO
• UDI-Device Identifier: 07630971265585
• UDI-Public: 07630971265585
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220405
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: 01.20.212
• Device Lot Number: 2201597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2022
• 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
• Patient Race: White