MAUDE Adverse Event Report: DEPUY SYNTHES, INC. HV CEMENT; BONE CEMENT

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 12/04/2013

Event Type  Injury  

Event Description

I had a total knee replacement in (b)(6) 2013 @ (b)(6) hospital in (b)(6).Performed by dr.(b)(6).I am single/live alone/no one to care or help with my care.After 4 days in the hospital, i was transferred to a nursing home for a 20 day stay with therapy.It was a traumatic experience.I never was pain free.By (b)(6) 2016, i could stand the pain no longer.I went to the hospital and had x-rays which showed probable tibial plate loosening and possible infection.I had a nuclear medicine study performed within a month which ruled out infection.Because of the mental trauma i suffered after the replacement i continued to endure the pain until (b)(6) 2018 when i had a total knee revision done @ (b)(6) hospital in (b)(6).Performed by dr.(b)(6).His operative report documented the loosening of the tibial plate and the failure of the cement and debonding which had occurred.

• Brand Name: HV CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): DEPUY SYNTHES, INC.
• MDR Report Key: 8199733
• MDR Text Key: 131789472
• Report Number: MW5082627
• 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: Patient
• Type of Report: Initial
• Report Date: 12/23/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 127