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

Model Number 74122154

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Tissue Damage (2104); Toxicity (2333)

Event Date 07/22/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patient right hip on (b)(6)2020 due to unexplained pain, and elevated cobalt and chromium levels.Among the intra-operative findings there were metallosis, reactive synovial tissue with fibrinous degenerative and extensive macrophage reaction to pigmented metallic debris, consistent with a failed birmingham right hip resurfacing arthroplasty resulting from metal-on-metal wear and adverse metal reaction.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 and lot numbers a complaint history, dhr review and device labelling 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.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.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.

Manufacturer Narrative

H3, h6: it was reported that a right hip revision surgery was performed due to elevated cobalt and chromium levels and metallosis.Only the femoral head was explanted.The cup remains implanted.The devices were used in treatment, the explanted head was not returned for evaluation.A review of the historical complaints data for the devices involved was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint reopen date.One other complaint was identified to involve the bhr head batch.Other similar complaints were identified for both part numbers and the reported/related failure mode.This will continue to be monitored via routine trending.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes a risk management review was performed.No additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historic quality escalations related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documentation was reviewed.The reported pain and elevated cobalt and chromium levels, along with the intraoperative findings of metallosis and effusion, and pathological findings may be consistent with an adverse reaction to metal debris.However, based on the information provided the clinical root cause of the reported clinical reactions cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a malperformance of implant.The patient impact beyond the pain and revision cannot be determined.However, the patient was noted to be doing very well one month post revision.Based on the available 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 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.

Event Description

It was reported that a revision surgery was performed on the patient right hip on (b)(6) 2020 due to unexplained pain, and elevated cobalt and chromium levels.Among the intra-operative findings there were metallosis, reactive synovial tissue with fibrinous degenerative and extensive macrophage reaction to pigmented metallic debris, consistent with a failed birmingham right hip resurfacing arthroplasty resulting from metal-on-metal wear and adverse metal reaction.Only the femoral head was explanted.The cup remains within the patient.The patient outcome is unknown.

• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 5123913905
• MDR Report Key: 10624822
• MDR Text Key: 209753187
• Report Number: 3005975929-2020-00370
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552297
• UDI-Public: 03596010552297
• 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: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74122154
• Device Catalogue Number: 74122154
• Device Lot Number: 07HW13402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Sex: Male