MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74121150

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Metal Related Pathology (4530); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

Complaint reference: case-(b)(4).

Event Description

Bilateral patient.Plaintiff underwent medically-indicated revision of the bhr left hip implants on (b)(6) 2019.The revision surgery was performed due to metallosis, inflammatory tissue reaction, and highly elevated cobalt and chromium levels.The patient outcome is unknown.

Manufacturer Narrative

It was reported that left 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.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / ifu 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 device/ adequate 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.

Manufacturer Narrative

H3, h6: it was reported that left hip revision surgery was performed.During the revision, the bhr cup and head were removed.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.The available medical documents were reviewed.The left hip was revised in (b)(6) 2019 12 years post implantation.¿the cobalt and chromium levels have decreased; however, they are still elevated.(chromium level 3.6 and cobalt level 7.7).The left operative report documents; ¿a thorough debridement of all fibrous tissues and debris were removed.¿ the impact to the patient beyond the pain, the surgeries and the recovery cannot be determined.The clinical information provided, of the elevated metal ion levels and the metallosis debris, 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.

Event Description

Bilateral patient.It was reported that, after a left bhr on (b)(6) 2007, plaintiff experienced metallosis, inflammatory tissue reaction and highly elevated metal ions.Plaintiff underwent a right revision surgery on (b)(6) 2018 and a left revision on (b)(6) 2019.Patient outcome is unknown.

Manufacturer Narrative

Sections a2, a3, b5, b6 and b7 were updated due to new information received.

Manufacturer Narrative

H3, h6: it was reported that a left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu, or escalation actions review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed for the devices involved.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.The available medical documents were reviewed.The left hip was revised in november 2019, 12 ½ years post implantation.The stated indications were painful left hip resurfacing and metallosis.The metal ions were falling significantly, (b)(6) 2019 prior to the surgery - cobalt 7.7 g/l and chromium 3.6 g/l.Though they were still elevated.A thorough debridement of all fibrous tissue and debris were removed.However, there was no mention of metallosis or stained tissue in the operative report.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.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 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.

Manufacturer Narrative

H10: it was reported that a left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the resurfacing head.A review of historical complaints data was performed using the 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 aware date.Other similar complaints were identified for the part number and the reported/related failure mode.This will continue to be monitored.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.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.A review of the current ifu found adequate warnings and precautions in relation to the alleged failure modes.The available medical documents were reviewed.The left hip was revised in november 2019, 12 ½ years post implantation.The stated indications were painful left hip resurfacing and metallosis.The metal ions were falling significantly, (9-26-2019) prior to the surgery - cobalt 7.7 g/l and chromium 3.6 g/l.Though they were still elevated.A thorough debridement of all fibrous tissue and debris were removed.However, there was no mention of metallosis or stained tissue in the operative report.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.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, after a bhr left hip resurfacing surgery was performed on (b)(6) 2007 due to degenerative joint disease, the patient experienced pain, inflammatory tissue reaction and was diagnosed with metallosis.This event was treated by performing a revision surgery on (b)(6) 2019, in which both the femoral head and acetabular cup were replaced with a competitor¿s hip system (zimmer).Patient¿s current health status is unknown.

• Brand Name: BHR RESURFACING FEMORAL HEAD 50MM
• 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: 11073006
• MDR Text Key: 223634331
• Report Number: 3005975929-2020-00521
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74121150
• Device Catalogue Number: 74121150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2023
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 92 KG