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

Catalog Number	01.18.412
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components, performed a washout, and reimplanted permanent hardware.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 08 april 2024.Lot 2114214: (b)(4) items manufactured and released on 14-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 without any similar reported event during the period of review.Additional implants involved, batch review performed on 08 april 2024: ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot 2312444: (b)(4) items manufactured and released on 14-june-2023.Expiration date: 2028-05-22.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.Cup: mpact 01.32.156dh acetabular shell ø56 two-holes (k132879) lot 2213426: (b)(4) items manufactured and released on 28-sep-2022.Expiration date: 2027-09-09.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.Liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot 2301424: (b)(4) items manufactured and released on 29-march-2023.Expiration date: 2028-03-11.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.Screws: mpact 01.43.0030 cancellous bone screw ø 6,5 l 30 (k200391) lot 2245829: (b)(4) items manufactured and released on 21-march-2023.Expiration date: 2028-02-26.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.

• Brand Name: AMISTEM-P LAT STEM SIZE 2
• Common Device Name: HIP 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: 19079928
• Report Number: 3005180920-2024-00219
• Device Sequence Number: 6271828
• Product Code: LZO
• UDI-Device Identifier: 07630040720113
• UDI-Public: 07630040720113
• 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): 04/10/2024

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: 01.18.412
• Device Lot Number: 2114214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male