MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 46; CEMENTLESS HIP SHELL

Catalog Number	01.26.46MB
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 december 2018: lot 113444: (b)(4) pieces released on 30 august 2016.Expiration date: 2021-08-16 -totally, (b)(4) pieces produced- 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.Comment provided by medical affairs director: according to the surgeon, the issue was caused by having implanted a too big size for that patient, so no further analysis is necessary.
Event or Problem Description
The patient came in complaining of pain.The cause of pain was due to irritation of the psoas caused by the versafit dm cup being too large for the patients anatomy.The surgeon burred the edge of the dm cup to better fit the patients anatomy and revised the liner with another company's product.The surgeon revised the head with a medacta head and the surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 46
• Common Device Name: CEMENTLESS HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8141702
• Report Number: 3005180920-2018-00968
• Device Sequence Number: 1745645
• Product Code: MEH
• UDI-Device Identifier: 07630030808012
• UDI-Public: 07630030808012
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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: 08/16/2021
• Device Catalogue Number: 01.26.46MB
• Device Lot Number: 113444
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 12/07/2018
• 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