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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Pain (1994); Metal Related Pathology (4530)

Event Date 05/18/2020

Event Type  Injury  

Event Description

Us legal mdl - it was reported that a revision surgery of the bhr implants of the right hip on (b)(6) 2020 due to pain in hip and groin due to a pseudotumor and metallosis.Patient also presented difficulty walking; strength loss, metal debris, large pseudotumor, necrotic tissue, large amounts of cloudy fluid present, corrosion, elevated levels of cobalt and chromium, and other damage around the right-side hip joint.The patient outcome is unknown.

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.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.Dhr task closed as reasonable effort to obtain a lot/batch/serial number have not been successful.Should the lot/batch/serial number become available at a later date then the dhr task will be re-opened and completed.As no device batch numbers were provided for investigation, a manufacturing record review, ifu review could not be performed.A risk management review was performed.No additional risks were identified as result of the reported.If more information is received, this investigation will be reopened.The available medical documents were reviewed.The clinical information provided, of pseudotumor and trunnionosis may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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 warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11553314
• MDR Text Key: 241747548
• Report Number: 3005975929-2021-00153
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention