MAUDE Adverse Event Report: SMITH AND NEPHEW SMITH AND NEPHEW KNEE IMPLANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 71453257,41421208

Device Problems Loose or Intermittent Connection (1371); Loosening of Implant Not Related to Bone-Ingrowth (4002); Separation Problem (4043)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 07/12/2021

Event Type  Injury  

Event Description

On (b)(6) 2018 i had a (rt.Total knee repl) furnish by (smith and nephew) and the (cement) used was by (depuy).I experience off and on knee pain in or around ((b)(6) 2020) the pain continued and became problematic so i consulted my primary doctor on ((b)(6) 2021) he ordered xray's and referred me out to see an (orthopedic) on ((b)(6) 2021) who in turn stated that the xr's showed a (loosening of hardware) and a separation or deterioration between (cement and bone) he also stated that i will need (knee revision surgery) so he referred me to see a (joint specialist surgeon) but that appt isn't until ((b)(6) 2021) some (two months) from now so i'm constantly calling checking in for an earlier appt.And i have been place's on a call list for any cancellation, i have also e-mail the referring (ortho) if he could change his referral order from (routine to stat) but i have yet received a response; furthermore the (ortho) didn't palpate my knee to gauge the severity, he only viewed the xray's and didn't examining my knee for fear of further damage, you would think that raises the order to a (stat) level.Question: if judgements on lawsuits or settlements have already concluded what do present trauma patient do, does that mean that companies are off the hook until they are force to stop selling these devices.X ray's reveal the need for a knee revision, regarding the medical device i do have the implant records.Fda safety report id # (b)(4).

• Brand Name: SMITH AND NEPHEW KNEE IMPLANT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 12569671
• MDR Text Key: 275508362
• Report Number: MW5104365
• Device Sequence Number: 1
• Product Code: JWH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/30/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 71453257,41421208
• Device Lot Number: 14EM20140,13EM13589A,138M15481
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 64 YR
• Patient Weight: 93