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)

Event Date 05/10/2022

Event Type  Injury  

Event Description

It was reported that, after a r3-tha construct was implanted on the left hip on (b)(6) 2010, the plaintiff experienced elevated metal ion levels in blood.A revision surgery has already been medically indicated for (b)(6) 2023, although not yet conducted after more than a year of waiting due to covid-19.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: it was reported that, after a r3-tha construct was implanted on the left hip on (b)(6) 2010, the patient experienced elevated metal ion levels in blood.A revision surgery was indicated, but not confirmed as having been performed, for (b)(6) 2023.The devices, used in treatment, are therefore not available for analysis.As no device part and batch numbers were provided a complaint history review or manufacturing record reviews could not be performed.A review of the applicable ifus at the time of implantation found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed for the reported metal-related complications.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 in relation to r3 metal liners, modular head and sleeves was performed.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.It was reported that after a r3-tha construct was implanted on the left hip, the patient experienced elevated metal ion levels in blood.Cobalt 180 nmol/l (converted 10.60 ¿g/l)and chromium 15 nmol/l (converted 0.78 ¿g/l).A revision was noted to be scheduled for 30-mar-2023; however, no information regarding the revision has been provided.As of the date of this medical investigation, supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events cannot be determined with the information provided.Based on the information provided, further investigation of the reported complaint cannot be carried out 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 TN CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire TN CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16632431
• MDR Text Key: 312191315
• Report Number: 3005975929-2023-00020
• 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,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 04/24/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male