MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION Ø 36; HIP FEMORAL HEAD

Catalog Number	01.29.232H
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 february 2024: lot 2237506: 20 items manufactured and released on 02-dec-2022.Expiration date: 2027-11-15.No anomalies found related to the problem.To date, 17 items of the same lot have been sold with no similar reported event during the period of review.Additional component revised: liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot 2108143: (b)(4) items manufactured and released on 12-july-2021.Expiration date: 2026-06-30.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.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2021.On (b)(6) 2023, the patient came in reporting pain due to a fractured femur that was caused from falling.The surgeon revised the head and stem and the surgery was completed successfully.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.

• Brand Name: BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION Ø 36
• 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: 18902570
• Report Number: 3005180920-2024-00112
• Device Sequence Number: 9135598
• Product Code: LZO
• UDI-Device Identifier: 07630030809347
• UDI-Public: 07630030809347
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

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: 01.29.232H
• Device Lot Number: 2237506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2024
• Initial Report FDA Received Date: 03/14/2024
• 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
• Patient Weight: 111 KG
• Patient Race: White