MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL; CEMENTLESS ACETABULAR CUP

Catalog Number	01.32.162DH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 02 january 2019: lot 157832: (b)(4) items manufactured and released on 21 april 2016.Expiration date: 2021-04-13.No anomalies found related to the issue.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, the 62mm cup would not seat into the acetabulum.The surgeon removed the 62mm cup and implanted a 64mm cup with no issues.This caused a 5 minute delay in the case and the surgery was completed successfully.The agent stated the issue was discovered during the impaction phase and stated that the cup was loose inside of the acetabulum and would not fixate.The surgeon then elected to move up to the larger size cup.

• Brand Name: MPACT ACETABULAR SHELL
• Common Device Name: CEMENTLESS ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8207996
• Report Number: 3005180920-2018-01046
• Device Sequence Number: 2792155
• Product Code: LPH
• UDI-Device Identifier: 07630030810978
• UDI-Public: 07630030810978
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• 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): 01/02/2018

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: 04/13/2021
• Device Catalogue Number: 01.32.162DH
• Device Lot Number: 157832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 01/02/2019
• 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