MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI COCR FB FEM SZ 7 LM RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422367

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Injury (2348)

Event Date 10/25/2017

Event Type  Injury  

Event Description

It was reported that a manipulation under anesthesia was performed due to stiffening in the patient's left knee range of motion.

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: JUNI COCR FB FEM SZ 7 LM RL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8155582
• MDR Text Key: 130066887
• Report Number: 1020279-2018-02753
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010627506
• UDI-Public: 03596010627506
• Combination Product (y/n): N
• PMA/PMN Number: K073175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71422367
• Device Lot Number: C111160927
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention