MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120150

Device Problems Therapeutic or Diagnostic Output Failure (3023); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Pain (1994); Injury (2348); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/04/2018

Event Type  malfunction  

Event Description

It was reported a right hip revision due to pain, limited mobility, and metallosis.

Manufacturer Narrative

It was reported that 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.Based on the information provided, the bowl was not a complained device in this complaint and therefore has not been reviewed.A review of the complaint history for the bhr cup and bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the head.Similar complaints have been identified for the cup.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications 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.The available medical documents were reviewed.Based on the information provided, the reported pain, limited mobility, metallosis, fluid and infection may be consistent with findings associated with metal debris but based on the information provided metal debris was not reported, as well the reported infection could also explain the reported findings of the aspirate fluid but the pathology results were not provided.Without supporting post-primary and pre-revision radiographic images, lab/pathology reports, and/or the analysis of the explanted components, the source of the reported findings cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and expected post-operative healing/pain cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.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.

Manufacturer Narrative

New information: g4, d4.

• Brand Name: ACETLR CUP HAP 50MM 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: 9553168
• MDR Text Key: 178337728
• Report Number: 3005975929-2020-00003
• 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,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 74120150
• Device Lot Number: 088876
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71270068 VORTEX VACUUM BOWL 12GPD0001.; 74121142 RESURF FEM HEAD 42MM 086467.
• Patient Outcome(s): Hospitalization; Required Intervention