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

Model Number	01.18.443
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2024.Lot 2408154: (b)(4) items manufactured and released on 26-june-2024.Expiration date: 2029-06-12.No anomalies found related to the problem.To date,(b)(4) items of the same lot have been sold with no similar reported events during the period of review.Additional components involved and revised: batch review performed on (b)(6) 2024.Ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot 2417339: (b)(4) items manufactured and released on 01-july-2024.Expiration date: 2029-06-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Cup: mpact 01.32.158mht acetabular shell ø58 multi-hole t (k230011) lot 2338380: (b)(4) items manufactured and released on 25-june-2024.Expiration date: 2029-06-11.No anomalies found related to the problem.To date, (b)(4)items of the same lot have been sold with no similar reported events during the period of review.Liner: mpact 01.32.3652hct flat pe hc liner ø36/g (k103721) lot 2344541:(b)(4) items manufactured and released on 02-jan-2024.Expiration date: 2028-12-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Screws: mpact 01.43.0025 cancellous bone screw ø 6,5 l 25 (k200391) lot 2410266: (b)(4) items manufactured and released on 28-may-2024.Expiration date: 2029-05-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Screws: mpact 01.43.0030 cancellous bone screw ø 6,5 l 30 (k200391) lot 2410274: (b)(4)items manufactured and released on 22-may-2024.Expiration date: 2029-05-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Screws: mpact 01.43.0030 cancellous bone screw ø 6,5 l 30 (k200391) lot 2410276:(b)(4) items manufactured and released on 27-may-2024.Expiration date: 2029-05-07.No anomalies found related to the problem.To date,(b)(4) items of the same lot have been sold with no similar reported events during the period of review.Infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2024.Subsequently, the patient came in due to signs of infection and the pathogen was unknown.On (b)(6) 2024, the surgeon revised all implants.Presently, on (b)(6) 2024 the patient came in due to signs of infection and the pathogen is unknown.The surgeon explanted all implants and placed an antibiotic spacer.The surgery was completed successfully.

• Brand Name: AMISTEM-P COLLARED
• Common Device Name: AMISTEM-P COLLARED LAT STEM SIZE 3
• 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: 21135869
• Report Number: 3005180920-2024-01159
• Device Sequence Number: 20752449
• Product Code: LZO
• UDI-Device Identifier: 07630040720328
• UDI-Public: 07630040720328
• Combination Product (Y/N): N
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2025

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 Model Number: 01.18.443
• Device Lot Number: 2408154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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