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

Model Number 74121154

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that during thr surgery, the or staff gave the surgeon the wrong color coded combo, so the surgeon implanted an acetabular cup hap size 52/60 with a resurfacing femoral head 54mm.The procedure was completed with the same devices.No injury to patient reported.The sales rep realized about this issue two days after the case.For now it is unknown how this problem will be address.

Manufacturer Narrative

H3, h6.It was reported that during a total hip replacement surgery, the operating room staff gave the surgeon the wrong colour coated combination, so the surgeon implanted an acetabular cup hap size 52/60 with a resurfacing femoral head 54mm.No injury to patient was reported.As of today, the implanted devices, all of which were used in treatment, remain implanted.This issue was realised by the sales representative, two days after the surgery.A review of the historical complaints data for the acetabular cup and the femoral head was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.No other similar complaints were identified to involve these batches.No other similar complaints have been identified for the part numbers and the reported failure modes in this timeframe.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 manufacturing records did not reveal any waivers, concessions, manufacturing, or material abnormalities that could have contributed to this issue.A review of escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified; no further escalation actions required.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.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.The surgical technique states: ¿never mix colours on heads and cups.Compatible femoral and acetabular components are all the same colours.¿ the available medical documents were reviewed.Based on the catalogue numbers involved, this patient was originally implanted with a mismatched femoral head (label colour coded green) and acetabular component (label colour coded brown).The label colour matching of bhr implants is covered within the bhr surgical technique and surgeon training.Label colours on heads and acetabular cups are never to be mixed.Compatible femoral and acetabular components are all the same colours.This implantation of the mismatched components is a result of a medical staff error and is not related to a malperformance or failure of the implant.The patient impact cannot be determined; however, a 2 mm too large of a head on a shell for a metal-on-metal articulating bearing surface is not a valid combination and therefore the long-term effects is unknown but possibly an early revision is not ruled out.Based on the information provided, we can confirm this complaint.A probable root cause is associated with the procedure itself and the reported misassembly of the device.Based on this investigation, the need for corrective and preventative actions is not indicated.Internal reference number: (b)(4).

• 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: 12964470
• MDR Text Key: 281981846
• Report Number: 3005975929-2021-00562
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502803
• UDI-Public: 03596010502803
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• 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: 20AW06118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2020
• 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
• Patient Outcome(s): Other