MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 40; HIP FEMORAL HEAD

Catalog Number	01.29.233H
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month 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, head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 23 january 2024.Lot 2237507: (b)(4) items manufactured and released on 02-dec-2022.Expiration date: 2027-11-15.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 components involved: batch review performed on 23 january 2024.Liner: mpact 01.32.4048hct flat pe hc liner ø40/f (k122641) lot 2310981: (b)(4) items manufactured and released on 03-july-2023.Expiration date: 2028-06-12.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.Batch review performed on 23 january 2024.Stem: sms solid 01.36.070 sms solid stem lat size 10 (k181693) lot 2101520: (b)(4) items manufactured and released on 07-july-2021.Expiration date: 2026-05-20.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: BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 40
• Common Device Name: HIP FEMORAL 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: 18648765
• Report Number: 3005180920-2024-00033
• Device Sequence Number: 8264131
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2024

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: 01.29.233H
• Device Lot Number: 2237507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2022
• 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: Male