MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FACE-CHANGING 10 PE HC LINER 36/E; HIP INLAY

Model Number	01.32.3644HC10A
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 7 january 2021: lot 1810850: (b)(4) items manufactured and released on 22-mar-2019.Expiration date: 2024-03-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional items involved in the event, batch review performed on 7 january 2021.Ball heads: mectacer 01.29.232h head biolox option ø 36 (k131518) lot.19c0009: lot 19c0009: (b)(4) items manufactured and released on 30-jan-2019.Expiration date: 2024-01-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
4 months after the previous revision surgery the patient came in reporting pain due to a dislocation of the head from the liner.The surgeon revised the biolox head and sleeve, and face changing liner.The surgery was completed successfully.The first revision surgery was performed also due to dislocation (head and liner revised).

• Brand Name: LINER: MPACT FACE-CHANGING 10 PE HC LINER 36/E
• Common Device Name: HIP INLAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11207698
• Report Number: 3005180920-2021-00065
• Device Sequence Number: 3373036
• Product Code: LPH
• UDI-Device Identifier: 07630040731034
• UDI-Public: 07630040731034
• 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
• Report Date (Section B): 01/21/2021

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: 03/10/2024
• Device Model Number: 01.32.3644HC10A
• Device Catalogue Number: 01.32.3644HC10A
• Device Lot Number: 1810850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2020
• Initial Report FDA Received Date: 01/21/2021
• 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