MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 58; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.26.58MB
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	10/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 17 november 2017 the medical affairs director performed a clinical evaluation and commented as follows: 4 years after primary cementless tha with double mobility cup the acetabular component was found to be loose and then replaced.The supplied radiograph bears no date and it is possibly referring to early postoperative, before loosening of the cup took place.No specific finding can be observed on this documentation and the reason for loosening remains unknown.Batch review performed on 20 november 2017.(b)(4).To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in complaining of pain.The surgeon determined the cup was loose.The surgeon revised the cup, the liner and the head.The surgery was completed successfully.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 58
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7057482
• Report Number: 3005180920-2017-00699
• Device Sequence Number: 2004935
• Product Code: MEH
• UDI-Device Identifier: 07630030808203
• UDI-Public: 07630030808203
• 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: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2017

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: 03/31/2018
• Device Catalogue Number: 01.26.58MB
• Device Lot Number: 130122
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/24/2017
• 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
• Patient Age: 73 YR