MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE IMPLANT; PROSTHESIS, KNEE, PATLOFMRTIBIL, SMI-CNSTRIND, CMNTD,PLYMR/MTL/PLYMR

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Injury (2348)

Event Date 11/18/2019

Event Type  Injury  

Event Description

It was reported that the patient has components in place since 2011.Patella was painful and showed pathology on bone scans.Cystic changes behind it.A revision surgery was performed and the patella was explanted with bone cuts.Procedure went well.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, without the requested clinical information, a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The potential probable cause of this event is likely poor bone quality.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: KNEE IMPLANT
• Type of Device: PROSTHESIS, KNEE, PATLOFMRTIBIL, SMI-CNSTRIND, CMNTD,PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9471034
• MDR Text Key: 170854048
• Report Number: 1020279-2019-04396
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/15/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention