MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 1-2 RT 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027213
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2023 the patient experienced a loose from the tibial baseplate.This adverse event was solved by revision surgery on (b)(6) 2023 where the jrny ii bcs xlpe art isrt sz 1-2 rt 11mm was exchanged and a new 12mm 1-2 right journey ll poly was put in.Patient was stable.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed scratches and gouges in the surface of the device.The visual also reveals the device has damage along the base.A dimensional evaluation performed on the device revealed that that the device has damage that appears to be from the disassociation of the insert from the baseplate.The damage/deformation of several features would not allow for accurate measurement.The measurable critical feature that could be measured was within specification.This device is subjected to multiple visual and dimensional inspection during processing, and this type of damage has a high likelihood of detection during these inspections.The clinical/medical investigation concluded that, without supporting clinical documentation, we are unable to conclude whether the component loosening was a result from a failure to achieve adequate fixation in the primary surgery or if an external event led to the disassociation of the insert from the baseplate.Therefore, the definitive clinical factors, to the insert loosening could not be concluded and none of the events leading up to the loosening were reported that may be related.The impact to the patient was the reported loosening, the subsequent revision, and the post-operative convalescent period.Since it has been reported, the current health of the patient is stable, no further clinical/medical 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 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 knee systems revealed that looseness of components has been identified in possible adverse effects section as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, inadequate integration between the cement and bone/implant 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.We consider this investigation closed.
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2023 the jrny ii bcs xlpe art isrt sz 1-2 rt 11mm came loose from the tibial baseplate.This adverse event was solved by revision surgery on (b)(6) 2023 where the jrny ii bcs xlpe art isrt sz 1-2 rt 11mm was exchanged and a new 12mm 1-2 right journey ll poly was put in.Patient was stable.
Additional Manufacturer Narrative
H10: updated section h6 (clinical code).H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, without supporting clinical documentation, we are unable to conclude whether the component loosening was a result from a failure to achieve adequate fixation in the primary surgery or if an external event led to the disassociation of the insert from the baseplate.Therefore, the definitive clinical factors, to the insert loosening could not be concluded and none of the events leading up to the loosening were reported that may be related.The impact to the patient was the reported loosening, the subsequent revision, and the post-operative convalescent period.Since it has been reported, the current health of the patient is stable, no further clinical/medical 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 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 knee systems revealed that looseness of components has been identified in possible adverse effects section as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion, bone degeneration, size selected, inadequate integration between the cement and bone/implant, osteolysis and/or traumatic injury.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.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 1-2 RT 11MM
• 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: 18527109
• Report Number: 1020279-2024-00144
• Device Sequence Number: 6402751
• Product Code: JWH
• UDI-Device Identifier: 00885556178768
• UDI-Public: 00885556178768
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 74027213
• Device Lot Number: 23HM13637
• 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: 12/28/2023
• Supplement Date Received by Manufacturer: 02/13/2024; 03/07/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/14/2024; 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• 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
• Patient Sex: Unknown