MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT OFFSET 4MM PE HC LINER Ø40/F; HIP POLYETHYLENE HIGH-CROSS LINER

Model Number	01.32.4048HC4
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.At about 6 months from the primary the surgeon revised the head and liner and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 15 november 2022: lot 2111834: (b)(4) items manufactured and released on 19-oct-2021.Expiration date: 2026-10-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Batch review performed on 15 november 2022 on ball heads: mectacer 01.29.214 biolox delta ceramic ball head 12/14 ø 40 size l + 4 (k112115) lot.2107508 lot 2107508: (b)(4) items manufactured and released on 29-sept-2021.Expiration date: 2026-09-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: LINER: MPACT OFFSET 4MM PE HC LINER Ø40/F
• Common Device Name: HIP POLYETHYLENE HIGH-CROSS 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: 15860118
• Report Number: 3005180920-2022-00890
• Device Sequence Number: 5845824
• Product Code: LPH
• UDI-Device Identifier: 07630040731256
• UDI-Public: 07630040731256
• 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: 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): 11/24/2022

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: 10/05/2026
• Device Model Number: 01.32.4048HC4
• Device Catalogue Number: 01.32.4048HC4
• Device Lot Number: 2111834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2021
• 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: Male