MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS SIMPLEX BONE CEMENT

Lot Number RFW070

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 10/01/2015

Event Type  Injury  

Event Description

Have stryker total knee replacement (b)(6) 2015.Now (b)(6) 2018 - still knee hurts and swelling.Dr (b)(6) - lucency between femoral component and the femoral on the anterior aspect, right knee still giving out, "hale" osteoporosis, still wearing knee brace and cane, walker.Also there is a slight lateral tilt to the patella, stryer total knee replacement will not stop hurting, will not stop swelling, pains a lot.Dr (b)(6) said i need total knee replacement.Right knee gives out a lot - feel total knee replacement and getting loose.Dr (b)(6) said that "i explained that i don't think this is something that could be improved with revision surgery.".

• Brand Name: SIMPLEX BONE CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS
• MDR Report Key: 8019049
• MDR Text Key: 125749333
• Report Number: MW5080901
• Device Sequence Number: 2
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2018
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: RFW070
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 71 YR
• Patient Weight: 100