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

Model Number	01.32.3244HC4
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 6 november 2020.Lot#: 1810833: 50 items manufactured, and released on 4-mar-2019; expiration date: 2024-02-20.No anomalies found related to the problem.To date, 7 items of the same lot have been already sold without any similar reported event.Additional items involved in the event: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot#: 1811832.Batch review performed on 6 november 2020.Lot#: 1811832: 311 items manufactured and released on 2-apr-2019; expiration date: 2024-03-16.No anomalies found related to the problem.To date, 303 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in after 9 months from the primary surgery reporting pain due a dislocation of the head from the liner.The surgeon revised the cup, head, and liner.The surgery was completed successfully.

• Brand Name: LINER: MPACT OFFSET 4MM PE HC LINER 32/E
• Common Device Name: PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10905396
• Report Number: 3005180920-2020-00822
• Device Sequence Number: 3045594
• Product Code: LPH
• UDI-Device Identifier: 07630040730839
• UDI-Public: 07630040730839
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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: 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: 10/26/2020
• Initial Report FDA Received Date: 11/25/2020
• 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