MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71422263
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a manipulation under anesthesia was performed due to stiffening in the patient's left knee range of motion.
Additional Manufacturer Narrative
It was reported that a manipulation under anesthesia was performed due to stiffening in the patient's left knee range of motion.The associated juni cobalt chrome femoral component, juni tibial base plate and juni tibial insert were not returned for evaluation.Therefore a product analysis could not be performed.As the batch numbers provided were invalid, after repeated requests, smith and nephew has been unable to obtain the correct batch numbers.Thus, the device history record review cannot be completed.A review of the complaint history for the listed parts revealed prior complaints for the listed failure mode.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated at this time.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no patient medical information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: JOURNEY UNI TIBINRT S5-6LM/RL10MM
• 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: 8155924
• Report Number: 1020279-2018-02765
• Device Sequence Number: 13860636
• Product Code: HSX
• UDI-Device Identifier: 03596010582225
• UDI-Public: 03596010582225
• Combination Product (Y/N): N
• PMA/510(K) Number: K061011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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 Catalogue Number: 71422263
• Device Lot Number: C111151209
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 12/17/2019
• 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; Required Intervention