MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74123152

Device Problem Biocompatibility (2886)

Patient Problems Infiltration into Tissue (1931); Pain (1994)

Event Date 11/21/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a thr surgery was performed on (b)(6) 2019, the patient experienced pain over the course of the last year.Mri revealed some fluid collection around the implants.Co was 3.7ug/l (test mentioned results from non-certified test kit due to backorders) and cr was 3.0ug/l.This adverse event was treated by a revision surgery on (b)(6) 2022, in which a bhr resurfacing femoral head 52mm was exchanged.Patient's current health status is unknown.

Manufacturer Narrative

It was reported that a revision surgery was performed due to pain, fluid collection and metal ion levels.As of today, the implanted device used in treatment has not been returned for evaluation.A review of the historical complaints data for the femoral head was performed using batch number, part number and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for device, and this failure will continue to be monitored.In the absence of the actual device, the production records were reviewed for the device reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the product and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.Based on the reported symptoms it cannot be concluded that the events/clinical reactions of pain, fluid collection around implants, and metal ion levels in blood were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.No further clinical assessment is warranted at this time.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.H11: corrected information in h6 (health effect - clinical code).

• Brand Name: BHR RESURFACING FEMORAL HEAD 52MM
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15974798
• MDR Text Key: 305412604
• Report Number: 3005975929-2022-00490
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552433
• UDI-Public: 03596010552433
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74123152
• Device Catalogue Number: 74123152
• Device Lot Number: 19GW12337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Date Device Manufactured: 08/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention