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

Catalog Number	01.32.3244HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 february 2019: lot 182610: (b)(4) items manufactured and released on 18-jul-2018.Expiration date: 2023-07-03.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.An additional item was involved in the complaint.Ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 lot.184378 (k112115) : (b)(4) items manufactured and released on 10-oct-2018.Expiration date: 2023-09-26.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 (i&d and head and liner revision) due to signs of infection two weeks after the primary.A washout was then performed five days after revision surgery due to high level of bacteria (klebsiella pneumoniae).The surgery was completed successfully.

• Brand Name: LINER MPACT FLAT PE HC Ø32/E
• Common Device Name: HIP PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8377332
• Report Number: 3005180920-2019-00098
• Device Sequence Number: 193279
• Product Code: LPH
• UDI-Device Identifier: 07630030811913
• UDI-Public: 07630030811913
• 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): 02/28/2019

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: 07/03/2023
• Device Catalogue Number: 01.32.3244HCT
• Device Lot Number: 182610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/28/2019
• 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