MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI COCR FB FEM SZ 3 LM RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71422363
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a slow post-operative recovery due to pain, so the hospitalization was prolonged.
Additional Manufacturer Narrative
It was reported a slow post-op recovery due to pain.The affected juni femoral components, juni tibial baseplates and juni inserts, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A clinical analysis noted that the cause of pain during the immediate post- operative period of a bilateral knee is normal and is expected during the post- operative healing and rehab phase.Since no other interventions were required and the issue was reported as resolved, no further clinical/medical assessment is warranted at this time.Review of the ifu and risk management files identified the reported failure as potential adverse events.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: JUNI COCR FB FEM SZ 3 LM RL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8177596
• Report Number: 1020279-2018-02835
• Device Sequence Number: 19265997
• Product Code: HSX
• UDI-Device Identifier: 03596010627469
• UDI-Public: 03596010627469
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K073175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71422363
• Device Catalogue Number: 71422363
• Device Lot Number: 16KBP0009A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization