MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN R3 METAL LINER IMPL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problems Infiltration into Tissue (1931); Metal Related Pathology (4530)

Event Date 09/01/2020

Event Type  Injury  

Event Description

It was reported that the plaintiff underwent a first revision surgery of the right hip on (b)(6) 2020 due to elevated metal ion levels in blood.The operation was completed without complications.After this revision, the patient suffered from a second revision surgery (unspecified implants from an unspecified manufacturer) and keeps suffering from chronic pain and permanent reduction in mobility and day-to-day activities.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: it was reported that the plaintiff underwent a first revision surgery of the right hip due to elevated metal ion levels in blood.After a second revision surgery (unspecified implants from an unspecified manufacturer), the patient keeps suffering from chronic pain and permanent reduction in mobility and day-to-day activities.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu, or a definite escalation actions review could not be performed.If more information is received, this investigation will be reopened.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.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (elevated metal ion levels in blood) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.No further clinical assessment is warranted at this time.Based on the information provided we cannot confirm or further investigate the reported complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: UNKN R3 METAL LINER IMPL
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 14595472
• MDR Text Key: 293292462
• Report Number: 3005975929-2022-00376
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/09/2022
• 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
• Treatment: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE; UNKN R3 SHELL
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female