MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT OFFSET 4MM PE HC LINER 36/E; HIP SHELL LINER

Model Number	01.32.3644HC4
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06.July.2021: lot 1810835: (b)(4) items manufactured and released on 4-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 sold.No other similar events have been reported on this lot.Additional device involved: batch review performed on 06.July.2021: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot 187085: (b)(4) items manufactured and released on 12-dec-2018.Expiration date: 2023-12-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold.No other similar events have been reported on this lot.
Event or Problem Description
2 months after the primary surgery the patient came in reporting pain due to a dislocation of the head from the liner.The cause of the dislocation is unknown.The surgeon revised the cup, head and liner.

• Brand Name: MPACT OFFSET 4MM PE HC LINER 36/E
• Common Device Name: HIP SHELL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12157570
• Report Number: 3005180920-2021-00594
• Device Sequence Number: 4616380
• Product Code: LPH
• UDI-Device Identifier: 07630040731058
• UDI-Public: 07630040731058
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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: 02/20/2024
• Device Model Number: 01.32.3644HC4
• Device Catalogue Number: 01.32.3644HC4
• Device Lot Number: 1810835
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/13/2021
• 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