MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø36/E; FLAT LINER PE HC

Catalog Number	01.32.3644HCT
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 december 2023 lot 2248470: (b)(4) items manufactured and released on 02-march-2023.Expiration date: 2028-02-12.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 items involved in the event, batch review performed on 05 december 2023 ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2304158 lot 2304158: (b)(4) manufactured and released on 13-march-2023.Expiration date: 2028-02-20.No anomalies found related to the problem.To date, 121 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 6 months after the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø36/E
• Common Device Name: FLAT LINER PE HC
• 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: 18266874
• Report Number: 3005180920-2023-00995
• Device Sequence Number: 7691208
• Product Code: LPH
• UDI-Device Identifier: 07630030812118
• UDI-Public: 07630030812118
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2023

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: 01.32.3644HCT
• Device Lot Number: 2248470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2023
• 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: Female