MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKN01102102

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Injury (2348)

Event Date 02/23/2020

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to metallosis.Metal on metal acetabular cup was exchanged for a redapt modular cup.The patient outcome is unknown.

Manufacturer Narrative

It was reported that a hip revision surgery was performed.During the revision, the cup was removed.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.Without definitive part and lot numbers a complaint history, dhr review, device labelling and risk management cannot be performed for the devices involved.Should the lot/batch/serial number become available at a later date then the complaint history task will be re-opened and completed.The available medical documents were reviewed.It was reported that revision surgery was performed due to metallosis.Metal on metal acetabular cup to was exchanged to a redapt modular cup.The provided x-ray was reviewed and appears to show either stress shielding or osteolysis around the greater and lesser trochanter.The inclination or anteversion angle of the cup cannot be determined based on the image provided.The x-ray alone does not indicate an obvious reason for the reported metallosis.Should additional medical information be provided this complaint may be re-opened for further evaluation.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.

• Brand Name: UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE)
• 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: 10103309
• MDR Text Key: 193004525
• Report Number: 3005975929-2020-00165
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

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: Health Professional
• Device Catalogue Number: UNKN01102102
• Device Lot Number: NOT EXACT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN01000000 -UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN01102110 -UNKN BIRMINGHAM HIP HEMI HEAD; UNKN01102113 -UNKN BIRMINGHAM HIP HEAD SLEEVE
• Patient Outcome(s): Hospitalization; Required Intervention