MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74121154

Device Problems Corroded (1131); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Implant Pain (4561); Insufficient Information (4580)

Event Date 09/23/2022

Event Type  Injury  

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

It was reported that, after a bhr system had been implanted on an unspecified date, the plaintiff experienced an unspecified adverse event that was addressed via revision surgery on (b)(6) 2022.No additional information was provided.

Manufacturer Narrative

It was reported that a revision surgery was performed due to an unspecified adverse event.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, or definite escalation actions review could not be performed.A review of the product¿s instructions for use was not possible due to limited information about the details of the event and device.Without basic part details or an alleged failure mode, no risk file review is possible.No further actions are required at this time.If more information is received, this investigation will be reopened.The requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the unspecified complications.With the limited information provided, the patient impact beyond the reported revision cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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

H3, h6: it was reported that a right hip revision surgery was performed due to pain and corrosion on the implant.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 device.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.Similar complaints have been identified for the cup and the head, and this failure will continue to be monitored.As no device batch numbers were provided for investigation, manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The review of the most recent 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 reported right hip pain may be consistent with the reported osteoarthritis.With the limited information provided, the clinical root cause of the reported corrosion or its location could not be confirmed.It cannot be concluded if this is implying a trunnion corrosion or something different.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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 right hip resurfacing (bhr) was performed on (b)(6) 2011 due to osteoarthritis and hip pain subsequent to a work injury, the patient experienced pain along with implant corrosion.This complication was treated by performing a revision surgery on (b)(6) 2022, in which both resurfacing components were explanted, and a competitor¿s tha system (stryker) was placed in exchange.During this procedure, synovial fluid samples were collected; however, test results are not available at this time.The patient returned to the pacl in stable condition.

Manufacturer Narrative

Additional information: a2, b5, b7, d1, d4, d6a, d10, h6 b3, d6b, g2.

• Brand Name: RESURFACING FEMORAL HEAD 54MM
• 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: 16928309
• MDR Text Key: 315167941
• Report Number: 3005975929-2023-00067
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502803
• UDI-Public: 03596010502803
• 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,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74121154
• Device Catalogue Number: 74121154
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2023
• 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
• Treatment: 74120162/ACETLR CUP HAP 62MM W/ IMPTR
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male