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

Catalog Number	01.32.3244HCT
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 january 2019.Lot 179361: (b)(4) items manufactured and released on 25 april 2018.Expiration date:2023-04-13.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.Other device involved: cocr ball head 12/14 ø 32 size l +3.5 reference 01.25.023 (k072857).Lot 172867: (b)(4) items manufactured and released on 13 september 2017.Expiration date: 2022-09-03.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.
Event or Problem Description
The patient came in, 2 months and 11 days after primary surgery, complaining of pain due a dislocation of the head from the liner.The dislocation occured when the patient raised her leg in order to tie her shoe.The surgeon revised the cup, liner and head and the surgery was completed successfully.The surgeon used an anterior approach in the primary surgery.

• Brand Name: MPACT FLAT PE HC LINER Ø32/E
• Common Device Name: PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8270061
• Report Number: 3005180920-2019-00007
• Device Sequence Number: 1952706
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2019

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: 04/13/2023
• Device Catalogue Number: 01.32.3244HCT
• Device Lot Number: 179361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/23/2019
• 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