MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø60; UNCEMENTED ACETABULAR SHELL

Catalog Number	01.32.160MB
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 jun 2019: lot 185439: (b)(4) items manufactured and released on 22-oct-2018.Expiration date: 2023-10-14.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
During the primary hip surgery and after implanting the dm cup, the surgeon observed that the cup was loose.The surgeon removed the cup, and implanted a slurry bone graft and reimplanted the cup, but the cup was still loose.The surgeon chose to implant a multi hole cup with screws and the surgeon stated it was well fixated.The surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø60
• Common Device Name: UNCEMENTED ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8734042
• Report Number: 3005180920-2019-00524
• Device Sequence Number: 16787431
• Product Code: LPH
• UDI-Device Identifier: 07630030861017
• UDI-Public: 07630030861017
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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: 10/14/2023
• Device Catalogue Number: 01.32.160MB
• Device Lot Number: 185439
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/26/2019
• 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: Other