MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / F; LINER FLAT

Catalog Number	01.26.3248HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 august 2019- lot 179188: (b)(4) items manufactured and released on 21-mar-2018.Expiration date: 2023-03-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs manager: early infection in tha, few weeks after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Preliminary investigation performed by r&d project manager: head and liner covered in bio fluids.It is not possible to state any cause of explantation related to the implant.Additional implants involved in the event, batch review performed on 26 august 2019: ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot.1811830.Lot 1811830: (b)(4) items manufactured and released on 29-mar-2019.Expiration date: 2024-03-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
On the (b)(4) 2019 we were informed of a revision surgery planned and performed on the (b)(6) 2019.The patient had an infection.The surgeon decided that the infection needed to be washed out and the liner and head needed to be exchange 1 month and 1 day after primary.The surgery was completed successfully.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / F
• Common Device Name: LINER FLAT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9096673
• Report Number: 3005180920-2019-00788
• Device Sequence Number: 14144084
• Product Code: LZO
• UDI-Device Identifier: 07630030807619
• UDI-Public: 07630030807619
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

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 Expiration Date: 03/07/2023
• Device Catalogue Number: 01.26.3248HCT
• Device Lot Number: 179188
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 90