MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX OPTION HEADS; HIP CERAMIC BALL HEAD

Model Number	01.29.233H
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	09/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2021.On (b)(6) 2022, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised the head and the surgery was completed successfully.On (b)(6) 2023, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon revised the head, sleeve and liner.The surgery was completed successfully.Presently, on (b)(6) 2024, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 02 october 2024 lot 2213136: (b)(4) items manufactured and released on 13-sep-2022.Expiration date: 2027-08-29.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 implant revised: batch review performed on 02 october 2024 on liner: mpact 01.32.4052hct flat pe hc liner ø40/g (k103721) lot.2236038 lot 2236038: (b)(4) items manufactured and released on 26-oct-2022.Expiration date: 2027-10-09.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: MECTACER BIOLOX OPTION HEADS
• Common Device Name: HIP CERAMIC BALL HEAD
• 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: 20544237
• Report Number: 3005180920-2024-00852
• Device Sequence Number: 20801454
• Product Code: LZO
• UDI-Device Identifier: 07630030809354
• UDI-Public: 07630030809354
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

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 Model Number: 01.29.233H
• Device Lot Number: 2213136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male