MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY ACETABULAR SHELL 48; HIP CEMENTLESS SHELL

Model Number	01.32.148MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 december 2020: lot 182596: (b)(4) items manufactured and released on 03-august-2018.Expiration date: 2023-07-23.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 device involved: batch review performed on 10 december 2020: liner: mpact dm 01.26.2848mhc double mobility hc liner 28/dmd (k092265) lot 172720: (b)(4) items manufactured and released on 14-august-2017.Expiration date: 2022-07-20.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.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer, 1 year and 10 months after the primary.The patient only had a medacta cup and liner implanted during the primary.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48
• Common Device Name: HIP CEMENTLESS SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11045450
• Report Number: 3005180920-2020-00954
• Device Sequence Number: 19506183
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• 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): 12/21/2020

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: 07/23/2023
• Device Model Number: 01.32.148MB
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 182596
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/21/2020
• 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