MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD 52/28MM BH DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121652

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

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 01/14/2019

Event Type  Injury  

Event Description

It was reported that a second right hip revision was performed due to acute postoperative joint infection.

Manufacturer Narrative

It was reported that the second right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the dual mobility insert, bhr cup, oxinium head and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for cup, this failure will continue to be monitored.No other similar complaints were identified for the head, stem and the dual mobility insert.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.It was also confirmed that all devices were sterilised.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.Second right revision: approximately 3 weeks after the revision rt total hip replacement, the patient presented to the er with a sudden onset of rt hip pain and a low-grade fever.Upon being admitted, he continued to have fevers, and had elevated serologies; his wound began to have pinpoint drainage at its mid-portion.The root cause of the patient¿s i&d and total hip revision is the result of an acute postoperative periprosthetic joint infection.The infection is highly likely of an exogenous nature and a complication of the previous revision and there is no evidence that our product contributed to the infection.The patient impact beyond infection, revision and expected transient post op convalescence period cannot be determined.Based on available information the root cause is not a product related and a highly likely an external complication of the previous revision.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: 52/28MM BH DUAL MOBILITY INSERT
• 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: 9528627
• MDR Text Key: 172998736
• Report Number: 3005975929-2019-00451
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 74121652
• Device Lot Number: A1718652
• Date Manufacturer Received: 08/28/2020
• Patient Sequence Number: 1
• Treatment: 71309114 SYN POR PLUS HA HO STEM SZ 14 18JM00786; 71342800 OXI FEM HD 12/14 28MM +0 18KM03525; 74122158 ACETABULAR CUP HAP SIZE 52/58 17BW19770
• Patient Outcome(s): Hospitalization; Required Intervention