MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE IMPLANT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Device Problem Material Separation (1562)

Patient Problem Injury (2348)

Event Date 05/10/2019

Event Type  Injury  

Event Description

It was reported that the patient had a fall and the insert disengaged from the locking mechanism.It is unknown how was this resolved or the status of the patient.

Manufacturer Narrative

Additional information: event.

Event Description

It was reported that a revision surgery was performed after the patient had a fall and the insert disengaged from the locking mechanism.

Manufacturer Narrative

The associated complaint device was not returned.The medical investigation concluded that no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.Should clinical documentation become available in the future, the clinical/medical task may be re evaluated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re opened.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by j.Templeton, medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) without the requested clinical information a thorough medical investigation cannot be rendered.Should any additional medical information be provided this complaint will be re-assessed.

• Brand Name: KNEE IMPLANT
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8663516
• MDR Text Key: 146822881
• Report Number: 1020279-2019-02162
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention