MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F; HIP FLAT PE HC LINER

Catalog Number	01.32.3648HCT
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 december 2023: lot 2118355: (b)(4) manufactured and released on 01-feb-2022.Expiration date: 2027-01-20.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with another similar reported event in the period of review.Other device involved: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 2336701: (b)(4) manufactured and released on 19-sep-2023.Expiration date: 2028-09-03.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
Revision surgery for suspected infection at about 1 month from primary.The head and liner have been revised successfully.

• Brand Name: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F
• Common Device Name: HIP FLAT PE HC 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: 18474104
• Report Number: 3005180920-2023-01049
• Device Sequence Number: 6593974
• Product Code: LPH
• UDI-Device Identifier: 07630030812132
• UDI-Public: 07630030812132
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/09/2024

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: 01.32.3648HCT
• Device Lot Number: 2118355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2022
• 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 Age: 68 YR
• Patient Sex: Male