MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø32/D

Catalog Number	01.32.3241HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019.Lot 1900217: 121 items manufactured and released on 12-apr-2019.Expiration date: 2024-04-01.No anomalies found related to the problem.To date, 69 items of the same lot have been already sold without any similar reported event.Additional implant involved in the event, batch review performed on (b)(6) 2019.Ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot.1900796 lot 1900796: 280 items manufactured and released on 8-may-2019.Expiration date: 2024-04-27.No anomalies found related to the problem.To date, 126 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed 22 days after the primary due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/D
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9206478
• Report Number: 3005180920-2019-00883
• Device Sequence Number: 18944367
• Product Code: LPH
• UDI-Device Identifier: 07630030811876
• UDI-Public: 07630030811876
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2019

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: 04/01/2024
• Device Catalogue Number: 01.32.3241HCT
• Device Lot Number: 1900217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/18/2019
• 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