MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122158

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Toxicity (2333); Test Result (2695)

Event Date 02/14/2020

Event Type  Injury  

Event Description

It was reported that bhr revision surgery was performed due to increase in chromium levels, slight cyst formation behind cup, slight blackening of tissue present, black around the sleeve/taper junction of the prosthesis noted.

Manufacturer Narrative

Smith + nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith + nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith + nephew, or its employees, that the report constitutes an admission that the device, smith + nephew or its employees caused or contributed to the potential event described in this report.- attachment: [295113 summary.Pdf].

• Brand Name: ACETABULAR CUP HAP SIZE 52/58
• 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: 9739393
• MDR Text Key: 183911733
• Report Number: 3005975929-2020-00072
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• 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: 04/28/2020

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: Lay User/Patient
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 04/03/2020
• Supplement Dates FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODULAR HEAD 74222152/ UNKNOWN.; MODULAR SLEEVE 74222300/ UNKNOWN.; POLARSTEM 75002126/ UNKNOWN.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR