MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DOUBLE MOBILITY HC LINER Ø 50/28; ACETABULAR LINER DOUBLE MOBILITY

Catalog Number	01.26.2850MHC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30-aug-2023 lot 2302831: (b)(4) items manufactured and released on 13-apr-2023.Expiration date: 2028-03-22.No anomalies found related to the problem.To date, 52 items of the same lot have been sold with no similar reported event during the period of review.Additional component involved: cup: mpact 01.32.150mb double mobility acetabular shell ø50 (k143453) lot.2247253: 32 items manufactured and released on 31-may-2023.Expiration date: 2028-05-16.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
On the same day of the primary, the patient sustained a joint dislocation.The surgeon performed surgery on the patient again and revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: MPACT DOUBLE MOBILITY HC LINER Ø 50/28
• Common Device Name: ACETABULAR LINER DOUBLE MOBILITY
• 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: 17649308
• Report Number: 3005180920-2023-00652
• Device Sequence Number: 7502633
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 08/30/2023

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 Catalogue Number: 01.26.2850MHC
• Device Lot Number: 2302831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2023
• 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 Age: 56 YR
• Patient Sex: Female