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

Model Number	01.32.3241HC10A
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 3 february 2022.Lot 187105: (b)(4) items manufactured and released on 06-dec-2018.Expiration date: 2023-nov-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional item involved in the event, batch review performed on 3 february 2022.Ball heads: mectacer 01.29.231h head biolox option ø 32 (k131518) lot.187105 lot 187105: (b)(4) items manufactured and released on 06-dec-2018.Expiration date: 2023-nov-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2019.On (b)(6) 2019, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised the head and liner and the surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised all components and the surgery was completed successfully.

• Brand Name: LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø32/D
• Common Device Name: FACE CHANGING PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13634778
• Report Number: 3005180920-2022-00145
• Device Sequence Number: 14752753
• Product Code: LPH
• UDI-Device Identifier: 07630040730778
• UDI-Public: 07630040730778
• 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: 2019
• Device Explanted Year: 2022
• 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): 03/01/2022

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: 03/03/2024
• Device Model Number: 01.32.3241HC10A
• Device Catalogue Number: 01.32.3241HC10A
• Device Lot Number: 1810848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2019
• 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: Male