MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FACE-CHANGING 10° PE HC LINER Ø32/C; HIP SHELL LINER

Model Number	01.32.3239HC10A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in reporting pain due to a joint luxation and the cause is unknown.The surgeon revised the head and liner and the surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in reporting pain due to another joint luxation and the cause is unknown.The surgeon revised successfully the cup, liner, and head.
Additional Manufacturer Narrative
Batch review performed on 15-feb-2023: lot 2009674: (b)(4) items manufactured and released on 28-jan-2021.Expiration date: 2026-01-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.Batch review performed on 15-feb-2023 ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115).Lot 2209198: (b)(4) items manufactured and released on 19-jul-2022.Expiration date: 2027-07-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.

• Brand Name: MPACT FACE-CHANGING 10° PE HC LINER Ø32/C
• Common Device Name: HIP SHELL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16378890
• Report Number: 3005180920-2023-00063
• Device Sequence Number: 5708822
• Product Code: LPH
• UDI-Device Identifier: 07630040730730
• UDI-Public: 07630040730730
• 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: 2022
• Device Explanted Year: 2023
• 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): 02/15/2023

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: 01/14/2026
• Device Model Number: 01.32.3239HC10A
• Device Catalogue Number: 01.32.3239HC10A
• Device Lot Number: 2009674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female