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

Catalog Number	01.18.433
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01-jul-2024: lot 2312572: (b)(4) items manufactured and released on 21-sep-2023.Expiration date: 2028-08-30.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.Addotional devices involved batch reviews performed on 01-jul-2024: liner: mpact dm 01.26.2852mhc double mobility hc liner 28/dmf (k092265) lot 2308555: (b)(4) items manufactured and released on 19-jun-2023.Expiration date: 2028-05-31.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 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 (k112115) lot 2237468: (b)(4) items manufactured and released on 13-dec-2022.Expiration date: 2027-11-27.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 or Problem Description
At about 2 months after primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the stem, head and liner.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM-P COLLARED 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: 19814524
• Report Number: 3005180920-2024-00540
• Device Sequence Number: 20999127
• Product Code: LZO
• UDI-Device Identifier: 07630040720229
• UDI-Public: 07630040720229
• 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: 2024
• 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): 07/24/2024

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: 01.18.433
• Device Lot Number: 2312572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2023
• 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 Sex: Unknown