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 Pain (1994); Discomfort (2330); Toxicity (2333)

Event Date 10/23/2019

Event Type  Injury  

Event Description

It was reported that left revision surgery was performed due to persistent pain, discomfort, popping and grinding sensation in the hip, symptoms of metallosis and high levels of cobalt and chromium in blood.

• 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: 10016693
• MDR Text Key: 189565170
• Report Number: 3005975929-2020-00126
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2020

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
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 74120156
• Device Lot Number: 087580
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 11/19/2020; 11/19/2020
• Supplement Dates FDA Received: 11/25/2020; 11/27/2020
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART AND LOT # UNKNOWN.; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention