MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS/ HOWMEDICA OSTEONICS CORP. SIMPLEX HV CEMENT; BONE CEMENT, ANTIBIOTIC

Device Problems Loose or Intermittent Connection (1371); Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 07/12/2017

Event Type  Injury  

Event Description

Not sure what date to use.Had left total knee replacement on (b)(6) 2017 (by surgeon dr.(b)(6) using depuy attune parts, and simplex hv cement with gentamicin).Took over 1 year to resolve all pain.Had a different surgery (left total hip replacement with pinnacle parts) on (b)(6) 2019 after which i had severe left thigh pain that eventually resolved to the left knee only.That surgeon felt the knee ligaments were a little too loose, so replaced the plastic component of the knee only on (b)(6) 2019 with a slightly larger attune component.Once the surgical pain resolved, the knee pain remained as before with minimal to no improvement.I had an instance of severe left knee pain with inability to bear weight on that leg for 3 days, (b)(6) 2020.No x-rays were taken that time, unfortunately.Since i had been treated for a uti the week before, it was questioned whether i had an infection in the joint.I was tested for protein(?) in the blood which was positive, but aspiration of the joint a week later was negative for infection.I got back to being able to weight bear, so nothing more was done at the time.I got a 2nd opinion (b)(6) 2021 (surgeon dr.(b)(6)) due to continued no further improvement in left knee pain, and x-rays show cystic changes in all the bones (femur, tibia, and patella) and subsidence of the tibial portion of the replacement into the tibia with tilting.I am scheduled to have the entire joint revised next week, (b)(6) 2021.This surgeon has stated there is a defect in the plastic component causing it to shed plastic particles which cannot be absorbed by the body, so it fights the cement and the bone instead, causing early loosening.He states he has seen this happen in other patients as well.My left knee pain was stable but in the last 3 months is worsening to the point i sometimes have to use a cane, have sharp pain if i step wrong, have bowing outward mildly at the knee, pain if i walk on uneven ground or walk too far, and severe pain the first few feet after resting/sitting for a while.The surgeon states i must have this revision or the bones may fracture, and even during this revision he fears my patella may fracture due to the thinning of the bone from the replacement defect.Fda safety report id # (b)(4).

• Brand Name: SIMPLEX HV CEMENT
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS/ HOWMEDICA OSTEONICS CORP.
• MDR Report Key: 11831588
• MDR Text Key: 251366152
• Report Number: MW5101372
• Device Sequence Number: 4
• Product Code: MBB
• 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: 05/12/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 106