MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN R3 METAL LINER IMPL

Catalog Number UNKN01100907

Device Problem Biocompatibility (2886)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)

Event Date 02/06/2020

Event Type  Injury  

Event Description

*us legal mdl* it was reported that, after a r3 tha construct had been implanted on an unknown date, the plaintiff experienced failed metal on metal articulation, elevated ion levels, pain, and disability.The plaintiff has failed the conservative nonsurgical management, which included ambulatory assistive devices, low impact exercise, and anti inflammatory medication.A revision surgery was performed on (b)(6) 2020 to treat these adverse events.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that, after a r3 tha construct had been implanted on an unknown date, the plaintiff experienced failed metal on metal articulation, elevated ion levels, pain, and disability.The plaintiff has failed the conservative nonsurgical management, which included ambulatory assistive devices, low impact exercise, and anti-inflammatory medication.A revision surgery was performed to treat these adverse events.All of the devices were used in treatment.As of today additional information has been requested for this complaint but has not become available.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / ifu review could not be performed.The devices would have met manufacturing specifications at the time of production.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 and no further actions are required at this time.The clinical information provided, of the reported elevated metal ion levels and black staining of the femoral stem may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and neither a definitive nor potential root cause can be determined.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: UNKN R3 METAL LINER IMPL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11910663
• MDR Text Key: 253470072
• Report Number: 3005975929-2021-00293
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01100907
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74222100, LOT: 09BW21797; UNKN ANTHOLOGY HIP IMPL; UNKN R3 SHELL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR