MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 48; CEMENTLESS HIP SHELL

Catalog Number	01.26.48MB
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: partial hip revision surgery (cup, head and liner) occurred 2 years and 4 months after cementless dual mobility total hip arthroplasty.According to the report the reason of pain could be soft tissue impingement but this cannot be confirmed on x-rays images.No other information useful for a clinical investigation has been supplied.Batch review performed on 27 february 2019: lot 160828: (b)(4) items manufactured and released on 25-may-2016.Expiration date: 2021-05-10.No anomalies found related to the problem.To date, all the items of this same lot have been already sold without any similar reported event.
Event or Problem Description
On january 31, 2019 we were informed about the fact that the surgeon was not pleased with the vertical placement of the cup and consequently would have revised the cup, head and liner on (b)(6) 2019.The revision was performed as planned and was completed successfully.According to the surgeon the pain was caused by the dm cup that was causing impingement of soft tissue.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
• Common Device Name: CEMENTLESS HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8374048
• Report Number: 3005180920-2019-00112
• Device Sequence Number: 13888206
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

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: 05/10/2021
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 160828
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/27/2019
• 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