MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø40/G; HIP ACETABULAR LINER

Catalog Number	01.32.4052HCT
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 2 july 2024: lot 2312023: (b)(4) items manufactured and released on 13-july-2023.Expiration date: 2028-06-28.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 component revised: cup: mpact 01.32.160dh acetabular shell ø60 two-holes (k132879) lot 2108090: (b)(4) items manufactured and released on 31-jan-2022.Expiration date: 2027-01-11.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) 2024.On (b)(6) 2024, the patient came in reporting pain due to a femoral fracture and the cause is unknown.The surgeon revised the stem and head with competitor components.The surgery was completed successfully.On (b)(6) 2024 the patient had signs of infection and the pathogen is unknown.The surgeon removed the medacta cup and liner and competitor stem and head to implant an antibiotic spacer.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø40/G
• Common Device Name: HIP ACETABULAR LINER
• 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: 19836133
• Report Number: 3005180920-2024-00544
• Device Sequence Number: 7594832
• Product Code: LZO
• UDI-Device Identifier: 07630030812286
• UDI-Public: 07630030812286
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122641
• 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): 07/26/2024

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: 01.32.4052HCT
• Device Lot Number: 2312023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• 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