MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74123156
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the plaintiff underwent a right hip resurfacing arthroplasty on (b)(6) 2015 due to groin pain after a car crash.Afterward, revision surgery was performed on (b)(6) 2022 due to persistent right hip pain and suspected metallosis.During the procedure, the femoral head was explanted.It was noticed that the patient had significant darkening of the synovium around the acetabulum in ring, suggestive of a small degree of metallosis occurring at the junction of the metal-metal interface.It is unknown the current state of the patient.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Results of investigation: it was reported that right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.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 femoral head part number and the reported/related failure mode.Similar complaints have been identified for the acetabular cup part number and the reported/related failure mode.This will continue to be monitored.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, no prior applicable escalation actions were identified.The available medical documents were reviewed.The clinical information provided, of significant darkening of the synovium around the acetabulum in a ring 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 an implant failure.The patient impact beyond the revision cannot be determined with the information provided.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.¿.

• Brand Name: BHR RESURFACING FEMORAL HEAD 56MM
• 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: 15204085
• Report Number: 3005975929-2022-00453
• Device Sequence Number: 14635216
• Product Code: NXT
• UDI-Device Identifier: 03596010552440
• UDI-Public: 03596010552440
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2019
• Device Model Number: 74123156
• Device Catalogue Number: 74123156
• Device Lot Number: 14JW15363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2014
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male