MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT OFFSET 4MM PE HC LINER 32/E; HIP SHELL LINER

Model Number	01.32.3244HC4
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 september 2020: lot 1810833:(b)(4) items manufactured and released on 04-mar-2019.Expiration date: 2024-02-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional device involved: batch review performed on 02 september 2020: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115), lot 1810833: (b)(4) items manufactured and released on (b)(4) 2019.Expiration date: 2024-02-20.No anomalies found related to the problem.To date, 5 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in for a post-op appointment and it was observed that the hip joint dislocated anteriorly.The surgeon decided to perform a closed reduction under anesthesia but the patient's hip did not remain stable.The surgeon decided to open up the patient and revise the head and liner for stability 2 months and a half after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
On january 22nd 2021 we have recevied the following informaton: the revision surgery was performed on (b)(6) 2020.

• Brand Name: LINER: MPACT OFFSET 4MM PE HC LINER 32/E
• Common Device Name: HIP SHELL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10526942
• Report Number: 3005180920-2020-00619
• Device Sequence Number: 19634096
• Product Code: LPH
• UDI-Device Identifier: 07630040730839
• UDI-Public: 07630040730839
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2024
• Device Model Number: 01.32.3244HC4
• Device Catalogue Number: 01.32.3244HC4
• Device Lot Number: 1810833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 02/19/2021
• 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: Other; Required Intervention