MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER 32/F; ACETABULAR PE HC LINER

Model Number	01.32.3248HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 may 2021: lot 2009605: (b)(4) items manufactured and released on 22-oct-2020.Expiration date: 2025-10-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: ball heads: cocr 01.25.023 cocr ball head 12/14 ø 32 size l +3.5 (k072857) lot.2006285.Batch review performed on 31 may 2021: lot 2006285: (b)(4) items manufactured and released on 22-sept-2020.Expiration date: 2025-09-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager.Hip dislocation 5 weeks after primary implantation.Poor quality of the radiographic image provided doesn't allow a proper clinical evaluation.Hip dislocation may be due to component positioning or insufficient soft tissue tensioning; it can hardly be caused by standard devices.
Event or Problem Description
Revision surgery 1 month after primary for luxation of the head from liner (happened during rehab).Double mobility converter implanted successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER 32/F
• Common Device Name: ACETABULAR PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12056933
• Report Number: 3005180920-2021-00523
• Device Sequence Number: 19800839
• Product Code: LPH
• UDI-Device Identifier: 07630030811951
• UDI-Public: 07630030811951
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 06/24/2021

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: 10/08/2025
• Device Model Number: 01.32.3248HCT
• Device Catalogue Number: 01.32.3248HCT
• Device Lot Number: 2009605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention