MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52; ACETABULAR CUP

Catalog Number	01.32.152MB
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 2 august 2019 by regulatory affairs department: lot 188880: (b)(4) items manufactured and released on 2 april 2019.Expiration date: 2024-03-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: liner: versafitcup dm 01.26.2852mhc double mobility hc liner 28/dmf (k092265) lot.1810745.Batch review performed on 2 august 2019 by regulatory affairs department: lot 1810745: (b)(4) items manufactured and released on 15 february 2019.Expiration date: 2024-01-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
Revision surgery performed after 4 days from the primary due to pain caused by a dislocation of the liner from the dm shell.The patient dislocated due to an amputated left pelvis and leg.The surgeon revised the liner, cup and the head.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8906040
• Report Number: 3005180920-2019-00687
• Device Sequence Number: 16781252
• Product Code: LPH
• UDI-Device Identifier: 07630030860973
• UDI-Public: 07630030860973
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2019

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: 03/24/2024
• Device Catalogue Number: 01.32.152MB
• Device Lot Number: 188880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2019
• Initial Report FDA Received Date: 08/19/2019
• 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