MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER 32/E; ACETABULAR PE HC LINER

Model Number	01.32.3244HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16.Mar.2021: lot 186966: (b)(4) items manufactured and released on 19-oct-2018.Expiration date: 2023-10-02.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 implant involved: ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot.1901937.Batch review performed on 16.Mar.2021: lot 1901937: (b)(4) items manufactured and released on 17-jun-2019.Expiration date: 2024-06-01.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.
Event or Problem Description
The patient came in 1 year and 5 months after the primary surgery reporting pain due to a dislocation of the head from the liner.The surgeon revised the head and liner and added a sleeve.The surgery was completed successfully.The surgeon noticed that the patient's leg was a bit short in length compared to his other leg, so he decided to upsize the head during the revision to give the patient more length in his leg.

• Brand Name: LINER: MPACT FLAT PE HC LINER 32/E
• Common Device Name: ACETABULAR PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11587644
• Report Number: 3005180920-2021-00253
• Device Sequence Number: 4297252
• Product Code: LPH
• UDI-Device Identifier: 07630030811913
• UDI-Public: 07630030811913
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2023
• Device Model Number: 01.32.3244HCT
• Device Catalogue Number: 01.32.3244HCT
• Device Lot Number: 186966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/30/2021
• 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: Required Intervention