MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120156

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Pain (1994)

Event Date 01/15/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pain.An acetabular cyst was noted on x-rays.Parts implanted 10 years prior.

• Brand Name: ACETLR CUP HAP 56MM 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 9610270
• MDR Text Key: 175659458
• Report Number: 3005975929-2020-00023
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 74120156
• Device Lot Number: 098878
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/20/2021
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN