MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT HOODED PE HC LINER Ø36/F; HOODED LINER

Catalog Number	01.32.3648HCAT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018: lot 166693: 70 items manufactured and released on (b)(6) 2016.Expiration date: 2021-11-03.No anomalies found related to the issue.To date, 27 items of the same lot have been already sold with one similar reported event.Other implant involved: mectacer biolox delta ceramic ball head 12/14 ø 36 size xl +8 reference 01.29.211 (k112115) lot 170703: 80 items manufactured and released on 31 may 2017.Expiration date: 2022-05-15.No anomalies found related to the issue.To date, 25 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of infection 1 month after primary.The pathogen will not become available.The surgeon washed out the hip and revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: MPACT HOODED PE HC LINER Ø36/F
• Common Device Name: HOODED LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7276209
• Report Number: 3005180920-2018-00050
• Device Sequence Number: 2006525
• Product Code: LPH
• UDI-Device Identifier: 07630030812125
• UDI-Public: 07630030812125
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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: 11/03/2021
• Device Catalogue Number: 01.32.3648HCAT
• Device Lot Number: 166693
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/16/2018
• 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: 75 YR