MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD PLATFORM SO CMTLSS FEM SZ5; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 74435845

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Synovitis (2094); Metal Related Pathology (4530)

Event Date 04/02/2021

Event Type  Injury  

Event Description

*us legal* it was reported that, after an r3-tha construct had been implanted on the patient¿s right hip on (b)(6) 2009, the patient experienced metallosis and pain.This adverse event was treated with a revision surgery on (b)(6) 2021.During this procedure, all components were explanted and replaced with a competitors¿ tha system.Intraoperatively, inflammatory synovial changes were noticed with a small gross macroscopic area with tissue staining.The trunnion showed mild signs of corrosion.The patient was transferred in a stable condition to the recovery room.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the clinical information provided, of tissue staining and corrosion on the trunnion 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.A review of the manufacturing records could not be performed, since the device history record for this production order was not available.This issue was escalated through our quality process.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed in adverse events in primary and revision surgery section that although rare, metal sensitivity reactions and/or allergic reactions to foreign materials have been reported in patients following joint replacement, which have required device removal.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include implant corrosion, irregular implant interaction, wear, abnormal motion over time or patient condition.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.H6: health effect - clinical code.

• Brand Name: PLATFORM SO CMTLSS FEM SZ5
• 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: 14487193
• MDR Text Key: 292482738
• Report Number: 3005975929-2022-00324
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010539960
• UDI-Public: 3596010539960
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Catalogue Number: 74435845
• Device Lot Number: 8886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 08/11/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: MODULAR SLEEVE +4MM 12/14-08FW17517
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 55 YR
• Patient Sex: Male