MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74123144

Device Problem Biocompatibility (2886)

Patient Problem Metal Related Pathology (4530)

Event Date 01/10/2022

Event Type  Injury  

Event Description

Bilateral patient.It was reported that, after a bilateral bhr resurfacing construct had been implanted on the patient¿s left and right hip on (b)(6) 2009 respectively, the patient required a revision arthroplasty of the right hip implants on (b)(6) 2022.Among the reported symptoms that made necessary this intervention, the patient experienced elevated cobalt levels in blood referred as to be ¿in the upper 40's¿.Although there is no evidence of any intervention performed on the left bhr resurfacing implants, the contribution of this prosthesis to the reported cobalt levels could not be discarded.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: it was reported that after a bhr resurfacing construct had been implanted on the patient¿s left hip, the patient experienced elevated cobalt levels in blood.There is no evidence of any intervention performed on the left bhr resurfacing implants, but the patient underwent revision surgery for the right hip.As of today, the implanted devices, all of which were used in treatment are not accessible for intervention.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the acetabular cup and similar complaints have been identified for the femoral head.However, as the devices are 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 released devices involved met manufacturing specifications upon release for distribution.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 products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.Although elevated cobalt was reported, no units of measure nor lab reports were provided.With the limited information provided the clinical root cause of the reported elevated cobalt cannot be confirmed.It cannot be concluded the elevated cobalt was associated with a malperformance of the implant or implant failure.No revision has been reported.Based on the information provided we cannot confirm or further investigate the reported complaint, 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 devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: FEMORAL HEAD 44MM
• 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: 14844913
• MDR Text Key: 295061337
• Report Number: 3005975929-2022-00409
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552419
• UDI-Public: 3596010552419
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

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 Expiration Date: 10/31/2011
• Device Catalogue Number: 74123144
• Device Lot Number: 9710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2267-2018 & Z-2268-201
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female