MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI OX FB FEM SZ 2 LM RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422342

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 01/03/2017

Event Type  Injury  

Event Description

It was reported that a conversion of partial knee arthroplasty to a total knee arthroplasty was performed due to pain and loosening of joint prosthesis.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and details regarding the patient¿s weight-bearing status, bone quality, and other additional clinical relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation and diagnostic images, the root cause of the reported pain and loosening cannot be determined.However, the ongoing pain is likely due to the loosening of the component, and based on the patient medical records the patient sustained multiple falls in injuries following her implantation, these injuries cannot be ruled out as contributing factors for loosening of the components.Although it was reported that the patient had a knee arthroscopy was performed on two different occasions no procedure documentation has been provided for review.It was also reported that the patient received several aspirations and without the results of the knee aspirations we are unable to rule out an infection as a contributory factor or the sutures which were removed in the second procedure.The patient impact beyond the procedures cannot be determined.No further clinical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: JUNI OX FB FEM SZ 2 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: 8348496
• MDR Text Key: 136444891
• Report Number: 1020279-2019-00648
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010627315
• UDI-Public: 03596010627315
• 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,other
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2019
• Device Catalogue Number: 71422342
• Device Lot Number: 09KM11626
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/18/2019
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR