MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE LM/RL SZ 3; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71422423
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after total knee arthroplasty was performed on an unknown date, the patient experienced loosening of implant.This adverse event will be treated with a revision surgery in the next 14 days.No further information is available at this time.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).Section d2 was corrected according to the information received.
Event or Problem Description
It was reported that, after total knee arthroplasty was performed on 02-aug-2019, the patient experienced loosening of tibial implant.This adverse event was treated with a revision surgery on 07-jun-2022.Patient is currently in a good health status.
Event or Problem Description
It was reported that, after a partial knee replacement had been performed on (b)(6) 2019 with a journey uni system, there was a noticeable accumulation of aseptic loosening of the jrny uni tibial base lm/rl sz 3.A revision surgery was conducted on (b)(6) 2022 to address this event.Patient is recovering.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H10 update: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device was returned with its mating plastic insert and femoral components.The tibial base and femoral component both had hardened bone cement present along the base of the devices.The insert was also slightly discolored from exposure to bodily fluids.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.The contribution of the device to the reported event could not be corroborated.Factors that could contribute to the reported event have been identified as but not limited to abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth, and traumatic injury.However, based on the documentation provided, the root cause of the event could not be definitively concluded; even though, the revision was due to the reported pain with aseptic loosening of the tibial baseplate.It is unknown if patient comorbidities or the size selection or placement of the component contributed to the reported event.The patient impact beyond the reported pain, loosening, and subsequent revision/conversion to tka could not be determined.Reportedly, the patient status is good.No further medical assessment can be rendered at this time.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 future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
H10: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device was returned with its mating plastic insert and femoral components.The tibial base and femoral component both had hardened bone cement present along the base of the devices.The insert was also slightly discolored from exposure to bodily fluids.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.The clinical/medical evaluation concluded that based on the documentation provided, the root cause of the event could not be definitively concluded; however, the revision was due to the reported pain with aseptic loosening of the tibial baseplate.It is unknown if patient comorbidities or the size selection or placement of the component contributed to the reported event.The patient impact beyond the reported pain, loosening, and subsequent revision/conversion to tka could not be determined.Reportedly, the patient status is good.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.The contribution of the device to the reported event could not be corroborated.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to abnormal motion over time, bone degeneration, design of device, fit/sizing, lack of ingrowth, lifetime of device, and 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 future complaints and investigate as necessary.We consider this investigation closed.Internal complaint reference number: (b)(4).

• Brand Name: JRNY UNI TIBIAL BASE LM/RL SZ 3
• 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: 14627628
• Report Number: 1020279-2022-02784
• Device Sequence Number: 4612854
• Product Code: HSX
• UDI-Device Identifier: 00885556087947
• UDI-Public: 00885556087947
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/09/2022
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 71422423
• Device Catalogue Number: 71422423
• Device Lot Number: 19BM02157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 06/14/2022; 06/17/2022; 07/08/2022; 09/08/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 06/15/2022; 06/29/2022; 07/28/2022; 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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: JOURNEY UNI TIBINRT S3-4LM/RL8MM, 19CM02018; JUNI COCR FB FEM SZ 4 LM RL, 18LBP0037A
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 87 KG