MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28; HIP FEMORAL HEAD

Catalog Number	01.29.230H
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2014.On (b)(6) 2024 shell, head and liner were revised successfully.The patient luxated his hip and sustained a closed reduction, but after this, in the x-rays done in the er, it was noticed that the shell was out of the acetabulum bone.It is unknown if the luxation was due to the cup failure or if the cup failure was generated during the closed reduction.Presently, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout, explanted all implants and placed an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 31 july 2024.Lot 2348073: (b)(4) manufactured and released on 09-jan-2024.Expiration date: 2028-12-11.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Additional component involved in the event: stem: masterloc 01.39.203 cementless ti coated lat stem size 3 (k160289) lot 2112247: (b)(4) manufactured and released on 10-jan-2022.Expiration date: 2026-12-21.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Stem:.

• Brand Name: BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28
• 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: 20005705
• Report Number: 3005180920-2024-00649
• Device Sequence Number: 11843563
• Product Code: LZO
• UDI-Device Identifier: 07630030809323
• UDI-Public: 07630030809323
• 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: 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): 08/20/2024

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: 01.29.230H
• Device Lot Number: 2348073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2024
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Race: White