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

Catalog Number UNKNOWN

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

Complaint reference: case-(b)(4).James stoney, clin ortho relat res (2020) 478:2625-2636 ¿clinical orthopaedics and related research 2020 - is the survivorship of birmingham hip resurfacing better than selected conventional hip arthroplasties in men younger than 65 years of age? a study from australia orthopaedic association national joint replacement registry.¿.

Event Description

It was reported that on literature review ¿clinical orthopaedics and related research 2020 - is the survivorship of birmingham hip resurfacing better than selected conventional hip arthroplasties in men younger than 65 years of age? a study from australia orthopaedic association national joint replacement registry.¿, 60 revision surgeries were reported due to loosening of the implant while using bhr components.

Manufacturer Narrative

H3, h6: it was reported within the literature review ¿clinical orthopaedics and related research 2020 - is the survivorship of birmingham hip resurfacing better than selected conventional hip arthroplasties in men younger than 65 years of age?¿, that bhr revision surgeries were performed due to loosening of the implants.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.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling/instructions for use review could not be performed.If more information is received, this investigation will be reopened.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.Smith and nephew has not received the explanted devices or adequate patient specific materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case 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) HEAD
• 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: 11232419
• MDR Text Key: 228850450
• Report Number: 3005975929-2021-00037
• 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,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention