MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABLR CUP HAP 44MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 12/03/2018

Event Type  Injury  

Event Description

It was reported that the patient walked, fell over and broke the femoral neck.A revision is required.The device was not damaged.

• Brand Name: ACETABLR CUP HAP 44MM W/ IMPTR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV313 HL; UK CV313HL
• MDR Report Key: 8193964
• MDR Text Key: 131323156
• Report Number: 3005975929-2018-00552
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/04/2019

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/24/2018
• Supplement Dates Manufacturer Received: 12/03/2018
• Supplement Dates FDA Received: 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention