MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74121146

Device Problem Biocompatibility (2886)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 05/10/2022

Event Type  Injury  

Event Description

It was reported that, after a hip construct consisting of a bhr resurfacing head and an r3 acetabular shell in combination with an r3 cocr liner had been implanted in the patient¿s left hip on (b)(6) 2011, the patient experienced metallosis.A revision surgery was performed on (b)(6) 2022 to treat this adverse event.During this procedure, a mild amount of metallic fluid within the soft tissues around the hip joint was noticed.The bhr resurfacing head was excised after a femoral neck cut was made based off preoperative templating.A new 40mm ceramic femoral head was impacted on an implanted size 7 high offset stem to complete the procedure.The patient¿s outcome is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Additional information added: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that a left hip construct was revised due to metallosis.During this procedure, metallic fluid and a dissociated liner were noticed.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 femoral head was performed using batch number, part number and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified.However, as the device is no longer sold, no action is to be taken.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, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions required.The available medical documents were reviewed.The under reaming of the acetabulum cannot be ruled out as a contributing factor to the intraoperative findings of an almost dissociated liner, intussuscepted liner within the socket, metallotic fluid, and corrosion on the back of the liner in the socket.Based on the information provided we cannot confirm or further investigate the reported 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.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.Corrected data: h3, h6 (health effect - clinical code, health effect - impact code).

• Brand Name: RESURFACING FEMORAL HEAD 46MM
• 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: 15087758
• MDR Text Key: 296458851
• Report Number: 3005975929-2022-00428
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502780
• UDI-Public: 03596010502780
• 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
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: 74121146
• Device Catalogue Number: 74121146
• Device Lot Number: 10DW26921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2010
• 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: PN: 71332530 / LOT: 11HM00044.; PN: 71335558 / LOT: 11LM04362.; PN: 71336530 / LOT: 11CT05252.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male