MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø40/F; HIP ACETABULAR LINER

Model Number	01.32.4048HCT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary surgery on (b)(6) 2022.On (b)(6) 2022, patient came in for a post-op appointment and the surgeon observed that the cup did not sit and the cause is unknown.The surgeon revised the cup, liner and head.The surgery was completed successfully.On (b)(6) 2022, the patient came in reporting pain due to joint luxation and the cause is unknown.The surgeon revised the cup, head and liner and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 11 november 2022.Lot: 1909329: (b)(4) manufactured and released on 12-dec-2019.Expiration date: 2024-12-01.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Additional component involved: ball heads: mectacer 01.29.212 biolox delta ceramic ball head 12/14 ø 40 size s - 4 (k112115) lot: 2001876: (b)(4) manufactured and released on 17-june-2020.Expiration date: 2025-06-04.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø40/F
• Common Device Name: HIP ACETABULAR 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: 15778464
• Report Number: 3005180920-2022-00833
• Device Sequence Number: 14670865
• Product Code: LZO
• UDI-Device Identifier: 07630030812262
• UDI-Public: 07630030812262
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 11/11/2022

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: 12/01/2024
• Device Model Number: 01.32.4048HCT
• Device Catalogue Number: 01.32.4048HCT
• Device Lot Number: 1909329
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2019
• 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: Female