MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023251
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Arthralgia (2355)
Date of Event	12/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after total knee arthroplasty was performed, the journey articular insert bcs standard 5-6 right broke.This adverse event was treated with revision surgery on (b)(6) 2022.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on the lack information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined.Should any additional clinical information be provided, this complaint will be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that fracture of implant components has been identified as possible adverse effects.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 product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
Additional information: a1, a2, a3, a4, d6a, d8.Corrected data: b3, b5, d9, h6 (health effect - clinical, health effect - impact code).
Event or Problem Description
It was reported that, after total knee arthroplasty was performed on 10-feb-2009, the patient experienced "cracking" in the knee joint when he wanted to get up and pain when stretching the knee joint.These symptoms appeared on (b)(6) 2021.As there was no improvement in symptoms despite conservative therapy measures, this adverse event was treated with revision surgery on (b)(6) 2022.During this surgery, it was observed that the post of a journey articular insert bcs standard 5-6 right was fractured in the distal third, and the broken proximal fragment was recovered.In addition, moderate synovitis was found intraoperatively and a synovectomy was performed.A synovial biopsy of the right knee was conducted, in which no evidence of cellular and microbial structures were observed.
Additional Manufacturer Narrative
Section h10: the associated device was returned and evaluated.The visual inspection revealed the device was found to be fractured along the post, rendering the device inoperative.The device's fractured post was also returned with the device.A lab analysis performed on the device revealed signs of burnishing wear on the condyles and extraction damage of the implant on the articular surface and footprint.Extraction damage can occur as the result of contact with instrumentation during the removal process of the retrieved implant.Macroscopic/microscopic examination of the insert and fractured post showed damage related to the fracturing of the post from the insert at the post region surface of the insert and the anterior surface of the fracture post.The clinical/medical investigation concluded that, the revision operative report and visual inspection confirm the reported fracture of the insert.However, based on the information provided, the clinical root cause cannot be confirmed.The impact to the patient beyond that which has already been reported cannot be determined.No further clinical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed the complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.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.According with inspection procedure, the final inspection includes the verification of part configuration.Also, material specification shall control the quality and manufacture of ultra-high-molecular-weight polyethylene (uhmwpe) as ram-extruded gur 1050 rod and compression-molded gur 1020 rod.A review made by the quality engineering team revealed that the root cause of the fracture of the post could not be determined.There were no observations of material or manufacturing deviations in the course of this investigation.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include traumatic injury, abnormal loading and motion of the limb.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.Internal complaint reference number: (b)(4).

• Brand Name: JOURN ART INS BCS STD 5-6 RT 9
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 14983556
• Report Number: 1020279-2022-03289
• Device Sequence Number: 5035270
• Product Code: JWH
• UDI-Device Identifier: 03596010555137
• UDI-Public: 03596010555137
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/14/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2018
• Device Model Number: 74023251
• Device Catalogue Number: 74023251
• Device Lot Number: 08JM13756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 08/26/2022; 10/04/2022; 02/10/2023
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 09/08/2022; 10/07/2022; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2008
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 99 KG