MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74123144
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Arthralgia (2355); Metal Related Pathology (4530); High metal ion levels (4847)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that the patient underwent a right hip revision surgery on (b)(6) 2022 due to mechanical complication of internal prosthesis and metallosis.During the revision, the metallic cup was noticed to be well fixed, and it was retained.The metallic femoral head was explanted and replaced.The new system implanted was a tha with dual mobility liner.Primary right hip bhr procedure was performed on (b)(6) 2009.No further information is available.
Additional Manufacturer Narrative
It was reported that the patient underwent a right hip revision surgery due to mechanical complication of internal prosthesis and metallosis.During the revision, the metallic cup was noticed to be well fixed, and it was retained.The metallic femoral head was explanted and replaced.The new system implanted was a total hip arthroplasty with dual mobility liner.No further information is available.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 alleged devices was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.No other similar complaints have been identified for cup and head, and this failure will continue to be monitored via routine trending, however it should be noted that this device is no longer sold.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.The 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, 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 documents were reviewed.It should be noted the surgical technique indicates the acetabular component is to be impacted with 15-20° of anteversion.The implantation operative report indicated the acetabular component was implanted at about 20 to 25 degrees of anteversion.With the information provided a clinical root cause of the reported pain and elevated metal ions cannot be confirmed.The patient impact is the revision and postoperative convalescence period.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.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.
Additional Manufacturer Narrative
Corrected data: g2, h6 (health effect - clinical code).
Additional Manufacturer Narrative
H10.Additional information in b4.

• Brand Name: FEMORAL HEAD 44MM
• 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: 19402110
• Report Number: 3005975929-2024-00072
• Device Sequence Number: 8393626
• Product Code: NXT
• UDI-Device Identifier: 03596010552419
• UDI-Public: 3596010552419
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/30/2024

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 Expiration Date: 04/29/2013
• Device Catalogue Number: 74123144
• Device Lot Number: 08DW16604
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 06/12/2024; Not provided; 09/20/2024
• Initial Report FDA Received Date: 05/27/2024
• Supplement Report FDA Received Date: 06/13/2024; 07/17/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2008
• 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-2745-2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male