MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 38MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121138

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Gani, m.H., zahoor, u., hanna, s.A., & scott, g.(2022).Metal-on-metal hip resurfacing arthroplasty provides excellent long-term survivorship and function in patients with a good-sized femoral head: results of a single, non-designer surgeon¿s cohort.Bone & joint open, 3(1), 68-76.Doi: 10.1302/2633-1462.31.Bjo-2021-0135.R1/15.

Event Description

It was reported that on literature review "metal-on-metal hip resurfacing arthroplasty provides excellent long-term survivorship and function in patients with a good sized femoral head." 1 patient suffered femoral component loosening 13.83 years after a bhr and required a revision surgery.There's no more information available.

Manufacturer Narrative

H3, h6: it was reported that on literature review "metal-on-metal hip resurfacing arthroplasty provides excellent long-term survivorship and function in patients with a good sized femoral head.", one patient suffered femoral component loosening 13.83 years after a bhr and required a revision surgery.No further information is available and the devices, used in treatment, were not available for analysis.As no device batch numbers were provided for investigation manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the femoral head.A review of 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 as of the complaint aware date.No other similar complaints have been identified for the part number and the reported failure mode.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.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Based on the information provided we can confirm the reported complaint, however our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive patient weight, excessive physical activity levels, unreasonable stress on replacement system, trauma to the joint replacement.If additional information becomes available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.Internal complaint reference number: case-2022-00102911-1.

• Brand Name: RESURFACING FEMORAL HEAD 38MM
• 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: 14323142
• MDR Text Key: 291289306
• Report Number: 3005975929-2022-00243
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502766
• UDI-Public: 3596010502766
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74121138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2745-2015
• Patient Sequence Number: 1
• Treatment: UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TY)
• Patient Outcome(s): Required Intervention; Hospitalization