MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE SIZE 4 9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	00584202409
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint effusion (4849)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
*us legal* it was reported that after the patient underwent a left knee revision surgery for insert replacement on (b)(6) 2021, he kept suffering from pain, swelling and mild synovitis.On (b)(6) 2021, the patient was aspirated producing 50 cc of serosanguineous fluid and on (b)(6) 2021 the patient¿s left knee was aspirated again producing over 60 cc of dark bloody fluid.The patient continued with anti-inflammatory and physical therapy.The patient is currently in a lot of pain and continues to have swelling in the knee, is unable to climb stairs or bend the knee very much.The patient received a steroid shot but did not help with the pain.On (b)(6) 2022, the patient was re-evaluated due to persistent anterior knee pain with grade 3 chondrosis of the pf compartment (according to an mri).The patient was advised to have a conversion of the left uka to a tka, but he has not decided yet.
Additional Manufacturer Narrative
Internal complaint reference number: case-(b)(4).
Additional Manufacturer Narrative
Given the nature of the alleged incident, the devices could not be returned for evaluation.The clinical/medical investigation concluded that, although the progress notes show a left total knee arthroplasty is indicated, the ¿patient wants time to think about his decision, will follow up with me as needed¿, as of the date of this medical assessment, no confirmation has been received that the intervention was planned, scheduled, or performed.Reportedly, ¿hardware failure¿ and progression of patellofemoral chondrosis are the indications for the recommended revision/conversion to total knee arthroplasty; however, per the magnetic resonance imaging, ¿status post medial compartment hemiarthroplasty, no complications evident¿.Patient impact beyond the reported symptomatic disease progression, reported hardware failure, and left total knee arthroplasty indications/recommendations.Further patient impact cannot be determined.For all the devices a review of the instructions for use documents for zuk unicompartmental knee revealed that inflammation has been identified in adverse effects section.For the tibial base, device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file and prior actions review could not be performed.For the rest of the devices a review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed similar events for the listed batches, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management files 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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action is not indicated.Should 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.

• Brand Name: ARTICULAR SURFACE SIZE 4 9MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18655606
• Report Number: 1020279-2024-00299
• Device Sequence Number: 18169623
• Product Code: HSX
• UDI-Device Identifier: 00885556620168
• UDI-Public: 00885556620168
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K033363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00584202409
• Device Lot Number: 64199219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 00584200402 / LOT# 00584200402
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male