MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETLR CUP HAP 46MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120146
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Implant Pain (4561); High metal ion levels (4847)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: case-(b)(4).
Event or Problem Description
It was reported that a revision surgery was performed on the patient right hip on (b)(6) 2020.The revision surgery was performed due to chronic pain, fluid collection, and elevated chromium and cobalt levels from the mechanical failure of the right hip resurfacing arthroplasty, consistent with metal-on-metal wear.Among the intraoperative findings there was synovial fluid from the mechanical failure of the birmingham right hip resurfacing arthroplasty, resulting from metal-on-metal wear and adverse metal reaction.The patient outcome is unknown.
Additional Manufacturer Narrative
It was reported that 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.The available medical documents were reviewed.The revision operative report documents; ¿the patient has an extremely dysplastic and shrunken ileum secondary to radiation as a child for a wilms tumor.¿ elevated cobalt and chromium - cobalt level = 7.6 (no unit of measure provided)¿ a minimal amount of synovial fluid which was aspirated and sent for culture ¿ no infection was identified.¿ we encountered sclerotic bone behind the bhr stem.¿ the impact to the patient beyond the pain, the revision surgery, and the recovery cannot be determined.The clinical information provided, of the elevated metal ion levels and the pain, 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.It is unknown if the ¿sclerotic bone¿ was a result of the previous radiation or other undetermined causes.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 or Problem Description
It was reported that, after undergoing right hip resurfacing (bhr) on, the patient developed chronic hip pain, limited ability to ambulate.Upon clinical evaluation, she was found to present elevated cobalt and chrome levels in blood and right hip synovial tissue inflammation.In addition, and mri revealed bhr system mechanical failure.These complications were treated by conducting a conversion to total hip arthroplasty on (b)(6) 2020, in which the femoral resurfacing head was explanted and the acetabular cup was retained.A birmingham dual mobility xlpe insert was placed along with a polarstem femoral stem and an oxinium femoral head.Patient¿s outcome is unknown.
Additional Manufacturer Narrative
H10- additional information: a2- age at the time of event.A4- patient weight.B6- relevant tests.B7- other relevant history.D4¬- catalog number, unique identifier (udi) # h11- corrected data.B5- describe event or problem.D1- brand name.D6a / d6b- if implanted, give date/if explanted, give date ¿ please note that the acetabular component was not explanted.E1- initial reporter name and address.H6- evaluation codes.
Additional Manufacturer Narrative
It was reported that right hip revision surgery was performed due to pain, limited ability to ambulate, elevated cobalt and chromium levels and synovial tissue inflammation.An mri revealed bhr system mechanical failure.The devices, used in treatment, were not returned for analysis.As no device part and batch numbers were provided for investigation, a full complaint history review or manufacturing record review could not be performed.If more information is received, this investigation will be reopened.A review of the historical complaints data was performed, using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months to the complaint being reopened.No complaints were identified for either part in the year prior to the complaint being reopened.Complaint trends will continue to be monitoed via routine post market surveillance activities, however it should be noted that devices of this size are no longer sold.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.A review of the current product ifu found adequate warnings and precautions in relation to the alleged failure modes.A review of historical corrective and preventive actions, preliminary risk assessment, health hazard evaluations, and field 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 documentation was reviewed.In conclusion, the clinical root cause of the elevated metal ion levels and the pain cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.It is unknown if the ¿sclerotic bone¿ was a result of the previous radiation or other undetermined causes.The impact to the patient beyond the pain, the revision surgery, and the recovery cannot be determined.Based on the information provided we cannot further investigate the 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.If the products or additional information become available in the future, this case will be reopened.Based on this investigation the need for corrective and preventative action is not indicated.

• Brand Name: BHR ACETLR CUP HAP 46MM W/ IMPTR
• Common Device Name: 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: 11167339
• Report Number: 3005975929-2021-00003
• Device Sequence Number: 3494325
• Product Code: NXT
• UDI-Device Identifier: 03596010502544
• UDI-Public: 3596010502544
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/11/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 74120146
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 03/05/2021; 05/22/2023; 07/07/2023
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/11/2021; 06/07/2023; 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2267-2018,Z-2746-2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 70 KG