MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 LT13; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023264
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Arthralgia (2355); Joint Laxity (4526)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after tka surgery had been performed on an unspecified date, the surgeon has advised that a replacement of one (1) journ art ins bcs std 5-6 lt13 is required due to possible total or partial rupture of the posterior stabilization pad of the polyethylene insert.The revision surgery is not yet scheduled, but the surgeon plans to conduct an arthroscopy to confirm the diagnosis and change the insert at the same time if necessary.Current health status of patient is reported as "fine" but with knee instability.
Additional Manufacturer Narrative
Section d10 was updated.Section h10: the associated device was returned and evaluated.The visual inspection revealed the post of the insert fractured off.The broken post was not returned.The visual also reveals scratches, burrs and discoloration on the insert.The device shows signs of wear.A additional explant was returned as well.The visual of the patella reveals discoloration and gouges.A lab analysis performed on the device revealed the knee insert post deformation and/or fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.However, this could not be isolated as the root cause for this particular failure mode.The clinical/medical investigation concluded that, per complaint details, a revision was performed approximately 12 years post implantation due to suspicion of a partial/complete rupture of the insert pad (post).Reportedly, the revision consisted of an insert change, as well as the patella, ¿since on the one hand the prosthesis was placed more than 12 years ago and on the other hand the patient presented pains at this level.The surgeon thinks that the rupture of the insert of (is) linked to wear¿.It was communicated that the fracture of the insert was confirmed intraoperatively; however, the requested clinical documentation is not available.The visual inspection revealed ¿the post fractured off the insert¿ and ¿patella reveals signs of wear and deformation¿.As of the date of this assessment, the current patient health status is unknown.Based on the limited medical documentation provided, definitive contributing clinical factors cannot be concluded, although the length of time in-vivo could not be ruled out.Patient impact beyond the reported pain and instability, insert and patella revision with confirmation of a fractured insert cannot be determined.The current patient health status is unknown.No further medical assessment can be rendered 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 a similar event for the listed device over the previous 12 months, however no communalities that would suggest a device deficiency was found nor an adverse trend.In addition, 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 the implant can break or become damaged as a result of strenuous activity or trauma.The patient should be warned that the device does not replace normal healthy bone, this has been identified as warnings and precautions.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 per print.Also, material specification, the quality and manufacture of polyethylene as ram-extruded rod and compression-molded rod and plate shall be controlled.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 patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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: case-(b)(4).
Additional Manufacturer Narrative
Additional information: d6b (explantation date added).Corrected data: b5 (narrative updated as revision took place), d9 (device returned to manufacturer), h3 (device will be evaluated), h6(health effect - clinical code).
Event or Problem Description
It was reported that, after tka surgery had been performed approximately 12 years ago, the surgeon advised that a replacement of one (1) journ art ins bcs std 5-6 lt13 was probably required due to possible total or partial rupture of the posterior stabilization pad of the polyethylene insert.The revision surgery was performed on (b)(6) 2023.During this procedure, the fracture of the insert was confirmed.This prosthesis was replaced along with a patellar replacement as the patient presented pain at this level.Current health status of patient is unknown.

• Brand Name: JOURN ART INS BCS STD 5-6 LT13
• 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: 16415107
• Report Number: 1020279-2023-00385
• Device Sequence Number: 17020218
• Product Code: JWH
• UDI-Device Identifier: 03596010555236
• UDI-Public: 03596010555236
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2023

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: 03/01/2017
• Device Model Number: 74023264
• Device Catalogue Number: 74023264
• Device Lot Number: 07CM09219
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023; 06/08/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/27/2023; 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2007
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN JOURNEY KNEE PATELLAR COMPONENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown