MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY KNEE IMPL; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023271
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, an unkn journey knee impl was broken on insert which required a revision case to correct.All pieces were recovered.Current health status of the patient is unknown.
Additional Manufacturer Narrative
D4: part # and lot # were added.The associated device was returned and evaluated.The lab analysis confirmed that the as received tibial insert showed a fractured post with wear and deformation on the posterior surfaces of the fractured post tip.There was also wear and deformation at the base of the post which remained on the tibial insert.Additionally, wear, deformation, and scratching were observed on the articulating surface of the insert.Scratching was also observed on the anterior locking detail.The periphery of the insert locking detail was damaged.The post tip itself showed damage on the posterior and inferior surfaces.No material or manufacturing defects were observed in the component during investigation.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.The clinical/medical evaluation concluded that per the complaint details, a revision was performed due to a broken poly insert/post.It was communicated that the requested clinical documentation/information was not available.Without the requested documentation, the clinical root cause of the reported event could not be further assessed or concluded.The patient impact beyond the reported revision could not be determined.No further medical assessment is warranted 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.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of 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 future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
D4: udi # was added.

• Brand Name: UNKN JOURNEY KNEE IMPL
• 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: 12453037
• Report Number: 1020279-2021-06786
• Device Sequence Number: 14792438
• Product Code: JWH
• UDI-Device Identifier: 03596010555274
• UDI-Public: 03596010555274
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2022

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 Model Number: 74023271
• Device Catalogue Number: 74023271
• Device Lot Number: 09EM07319
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 03/29/2022; 03/29/2022
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 03/31/2022; 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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