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

Catalog Number	01.32.3644HCAT
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 january 2019.Lot 164682: 20 items manufactured and released on 05 october 2016.Expiration date: 2021-09-21.No anomalies found related to the problem.To date, 16 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2017 and subsequently dislocated.On (b)(6) 2018, the liner was revised with a medacta liner and the head was revised with another company's head.Presently, the patient came in due to a dislocation of the head from the liner.The surgeon revised the medacta cup and liner with another company's product and revised the competitor's head with another company's head.The surgery was completed successfully.A posterior approach was used in primary surgery.

• Brand Name: MPACT HOODED PE HC LINER Ø36/E
• Common Device Name: LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8230874
• Report Number: 3005180920-2018-01073
• Device Sequence Number: 16208955
• Product Code: LPH
• UDI-Device Identifier: 07630030812101
• UDI-Public: 07630030812101
• 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: 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): 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2021
• Device Catalogue Number: 01.32.3644HCAT
• Device Lot Number: 164682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 01/09/2019
• 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