MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT OFFSET 4MM PE HC LINER Ø36/G; HIP LINER

Catalog Number	01.32.3652HC4
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
In post-op recovery, the same day of the primary surgery, the patient suffered a joint luxation between our liner and competitor ball head.The surgeon revised the competitor stem and head, two medacta screws and liner and repositioned the medacta cup.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 15-jul-2024.Lot 2246042: (b)(4) items manufactured and released on 30-jan-2023.Expiration date: 2018-01-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: cup: mpact 01.32.162dh acetabular shell ø62 two-holes (k132879) lot 2301479: (b)(4) items manufactured and released on 06-jun-2023.Expiration date: 2028-05-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: LINER: MPACT OFFSET 4MM PE HC LINER Ø36/G
• Common Device Name: HIP 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19761737
• Report Number: 3005180920-2024-00528
• Device Sequence Number: 20952086
• Product Code: LPH
• UDI-Device Identifier: 07630040731133
• UDI-Public: 07630040731133
• 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: 2024
• Device Explanted Year: 2024
• 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): 07/17/2024

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: 01/16/2018
• Device Catalogue Number: 01.32.3652HC4
• Device Lot Number: 2246042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2023
• 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