MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN R3 METAL LINER IMPL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKNOWN

Device Problem Compatibility Problem (2960)

Patient Problem Injury (2348)

Event Date 10/21/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on (b)(6) 2018 on the patient right hip due to failure of right tha with synovitis, pain in the hip and groin region, tissue and nerve damage, and metallosis.Only the r3 metal liner, head and sleeve were explanted.A s&n 50x32mm +0 polyethelene r3 xple liner and a s&n oxinium 32m +8 femoral head were implanted.The patient outcome is unknown.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the r3 liner, head and sleeve were removed.The r3 shell and stem remained implanted.As of today, the revised devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.As no device part or batch numbers were provided for investigation, a complaint history, manufacturing record and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event.Smith and nephew has not received device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery was performed.During the revision, the r3 liner, head and sleeve were removed.The r3 shell and stem remained implanted.As of today, the revised devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.As no device batch numbers were provided for investigation, a manufacturing record review, (including a review of sterilisation certification), a complaint history review and a device labelling / instructions for use review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.The clinical information, metallosis fluid and corrosion may be consistent with a reaction to metal debris.However, the source cannot be determined.Additionally, the reported elevated erythrocyte sedimentation rate, c-reactive protein and operative findings of purulence may be consistent with streptococcus mutants.Although, the clinical root cause of the reported infection cannot be determined, it is of a hematogenous nature and is not associated with a mal-performance of the implant.The impact to the patient was the reported pain and revision.At six months post revision, the patient is now nearing normal function, showing no issues with getting the right leg in and out of car due to the right hip strength gains.He is showing no limp with gait if he is using the left shoe lift.According to the report, the patient is very pleased with the surgical outcomes currently.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: UNKN R3 METAL LINER IMPL
• 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: 10671680
• MDR Text Key: 211096430
• Report Number: 3005975929-2020-00382
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention