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

Catalog Number	01.32.3241HCAT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 july 2018.Lot 162414: 40 items manufactured and released on 19 may 2016.Expiration date: 2021-05-02.No anomalies found related to the problem.To date, 20 items of the same lot have been already sold without any similar reported event.Other device involved: mectacer biolox delta ceramic ball head 12/14 ø 32, size s -4, reference: (b)(4), lot 176360:170 items manufactured and released on 22 january 2018.Expiration date: 2023-01-10, no anomalies found related to the problem.To date, 132 items of the same lot have been already sold without any similar reported event.The supplier of the ball head has been informed and on 05 july 2018 they reported that the component properties and microstructures as obtained from the quality documents accomplish the requirements.There are no indications of any pre-existing material defect.
Event or Problem Description
On (b)(6) 2018 we were informed that patient is dislocating anteriorly, the head dislocated from the liner.Surgeon is going to change the liner orientation and the head offset.É revision surgery performed on (b)(6) 2018.Revision surgery completed successfully.

• Brand Name: MPACT HOODED PE HC LINER Ø32/D
• Common Device Name: PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7718453
• Report Number: 3005180920-2018-00533
• Device Sequence Number: 11011799
• Product Code: LPH
• UDI-Device Identifier: 07630030811869
• UDI-Public: 07630030811869
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132879
• 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): 07/25/2018

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: 05/02/2021
• Device Catalogue Number: 01.32.3241HCAT
• Device Lot Number: 162414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/25/2018
• 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: 88 YR