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

Catalog Number 74122554

Device Problems Compatibility Problem (2960); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Post Operative Wound Infection (2446); Neuralgia (4413); Metal Related Pathology (4530)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

This information was previously submitted under (manufacturer report number 3005975929-2020-00134), any further information received will be submitted under the current report.

Event Description

It was reported that a revision surgery was performed for failure of the left hip replacement due to metallosis, adverse tissue reaction.Elevated metal levels and fluid.The patient outcome is unknown.

Manufacturer Narrative

New information: g4, d4.

Manufacturer Narrative

H3, h6: it was reported that a left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.The hemi head and sleeve are no longer sold by smith & nephew.A review of the complaint history for the hemi head, modular sleeve, stem and bhr cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the head, cup & stem.Similar complaints were identified for the sleeve.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.The bhr cup, hemi head & sleeve met manufacturing specifications at the time of production.A non-conformance was identified for the manufacturing paperwork for stem.However, all supporting documents confirm that this was an acceptable product when released.It was also confirmed that all devices were sterilised.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The medical documents were reviewed.In conclusion, the clinical information provided, of the elevated metal ion levels, adverse tissue reaction and turbid fluid may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The post revision infection was caused by staphylococcus lugdunensis and precipitated the subsequent procedures and interventions.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: HEMI 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
• MDR Report Key: 10138927
• MDR Text Key: 194660684
• Report Number: 3005975929-2020-00189
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 74122554
• Device Lot Number: 08DW16544
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2021
• Patient Sequence Number: 1
• Treatment: 71306618 LOT 04BM16119; 74120160 LOT 10KW30360; 74222400 LOT 07FW12492; 71306618 LOT 04BM16119; 74120160 LOT 10KW30360; 74222400 LOT 07FW12492
• Patient Outcome(s): Hospitalization; Required Intervention