MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø32/C; CUP PE HC LINER

Catalog Number	01.32.3239HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 march 2019: lot 184749: (b)(4) items manufactured and released on 06-sep-2018.Expiration date: 2023-08-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot 178794: (b)(4) items manufactured and released on 03-may-2018.Expiration date: 2023-04-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery after about one month after the primary surgery due to infection (the pathogen is unknown).The surgeon performed a washout and revised the ceramic head and the cup insert.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/C
• Common Device Name: CUP PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8464661
• Report Number: 3005180920-2019-00205
• Device Sequence Number: 11098021
• Product Code: LPH
• UDI-Device Identifier: 07630030811845
• UDI-Public: 07630030811845
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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: 08/23/2023
• Device Catalogue Number: 01.32.3239HCT
• Device Lot Number: 184749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/29/2019
• 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