MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122158

Device Problem Component Misassembled (4004)

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

Event Date 12/21/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, upon inserting an acetabular cup hap size 52/58 in a bhr curved cup introducer, the surgeon noticed that the fixation fins were not correctly aligned.The plastic cap of the acetabular cup was disorientated, compromising a proper positioning of the implant on the patient's acetabulum.Given the fact that there were no back up implants, the surgeon requested a bhr streamline introducer to complete the procedure by positioning the same implant.A delay greater than 30 minutes was reported to occur during the bhr surgery.No patient harm was reported to occur due to this incident.

Manufacturer Narrative

Section b5 and d3 were updated according to the new information reviewed.Internal complaint reference number: (b)(4).

Event Description

It was reported that, upon inserting an acetabular cup hap size 52/58 in a bhr curved cup introducer, the surgeon noticed that the fixation fins were not correctly aligned.The plastic cap of the acetabular cup was disorientated, compromising a proper positioning of the implant on the patient's acetabulum.Given the fact that there were no back up implants, the surgeon requested a bhr streamline introducer to complete the procedure by positioning the same implant.A delay greater than 30 minutes was reported to occur during the bhr surgery.Surgeon states that the acetabular cup seems to be externally rotated as shown in post-operative x-rays.No patient harm was reported to occur due to this incident.Patient's current health status was reported as fine according to the surgeon.

Manufacturer Narrative

It was reported that during a bhr hip surgery, a bhr acetabular cup was identified to be incorrectly assembled to its plastic impactor, a surgical delay of 31-60 minutes was reported, no patient harm occurred.As of today, the acetabular cup used in treatment, remains implanted in the patient.On receipt of this information and confirmation through photographs received, a quality escalation was initiated to further investigate the reported product issues.This escalation included a hold on all parts with the same batch number and the initiation of a local non-conformance investigation.A review of escalation actions related to the product and similar complaint events was performed.Following the review, a similar event was identified.Previous corrective actions were initiated in the manufacturing process to reduce the risk of this error.A health hazard evaluation investigation which was previously performed as part of a quality investigation found there to be enough information to conclude that this was a set of isolated incidents which pose no further risk.No further escalation actions are required.A review of the historical complaints data for the acetabular cup 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 this batch.No other similar complaints have been identified for the part number and the reported failure mode in this timeframe.In the absence of the actual device, the production records were reviewed for the device reportedly involved in this incident.Review of the manufacturing records appeared to show that the device met manufacturing specifications at the time of production.However evidence provided has illustrated that the manufacturing record was not correctly completed in this case and that the part did not meet manufacturing specifications as the impactor cap was incorrectly assembled to the acetabular cup 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.The available medical documents were reviewed.The provided x-ray and photo were reviewed, but do not aid in the investigation of the clinical root cause of the reported events.It is unknown if the position of the implant is due to the patient¿s anatomy and morphology.Therefore, based on insufficient information, a thorough medical assessment could not be performed at this time.The impact to the patient beyond that which has already been reported cannot be determined.Based on this investigation, we can confirm this complaint and the root cause of the misalignment was operator error during the manufacturing process.

• Brand Name: ACETABULAR CUP HAP SIZE 52/58
• 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: 13195592
• MDR Text Key: 289335580
• Report Number: 3005975929-2022-00005
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 19LW18697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 90128257.