CEMENT BONE VISCOSITY 3092040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-13 for CEMENT BONE VISCOSITY 3092040 manufactured by Depuy/synthes.

Event Text Entries

[28837439] I received a knee replacement that was a defective failure that warranted a total revision right total knee replacement by dr (b)(6) 2014. After the replacement diagnosed with dvt's in both leg-in both legs (b)(6) 2014, confined to using a walker for ambulation. Received a right knee revision tibial spacer exchange possible tibia plate exchange. I discovered on date (b)(6) 2014 by dr. (b)(6) performing a revision operation in my right knee replacement of pad, tibial spacer exchange, that dr (b)(6) operation on date (b)(6) 2012 to my right knee, causing injury to my right knee,. I was harmed causing pain, and suffering. I discovered on date (b)(6) 2014 at a dr. Visit to dr. (b)(6) who informed me that i had blood clot in my right knee before operation on (b)(6) 2012. Dr. (b)(6) was negligent. I didn't know to get treatment from dr. (b)(6), i know now to get treatment from dr. (b)(6). I now got blood clot in both legs and knee due to dr. (b)(6) injury. I got to go to dr (b)(6) for one year to get the blood clots corrected. (b)(4) is named in product liability, the manufacturer for defective product, the knee is defective until dr. (b)(6) corrected it. The (b)(6) hospital was negligent, the hospital allowed dr. (b)(6) to perform the operation, they withheld, concealed the diagnosis from dr. (b)(6) that dvt's in right leg before the knee replacement, putting (b)(6) in danger of a heart attack or a stroke. Wouldn't have gone if (b)(6) hospital would not have told of the diagnosis of dvt's in legs. Wouldn't have gone back to dr (b)(6) to get treatment for the dvt's.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5057152
• MDR Report Key: 5161574
• Date Received: 2015-10-13
• Date of Report: 2015-10-05
• Date of Event: 2012-03-27
• Date Added to Maude: 2015-10-20
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: CEMENT BONE VISCOSITY
• Generic Name: CEMENT BONE VISCOSITY
• Product Code: LOD
• Date Received: 2015-10-13
• Model Number: 3092040
• Lot Number: 3307376
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY/SYNTHES

Device Sequence Number: 2

• Brand Name: CEMENT BONE VISCOSITY
• Generic Name: CEMENT BONE VISCOSITY
• Product Code: LOD
• Date Received: 2015-10-13
• Model Number: 3092040
• Lot Number: 3276745
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DEPUY/SYNTHES

Device Sequence Number: 3

• Brand Name: TIBIAL INSERT
• Generic Name: TIBIAL INSERT
• Product Code: HSH
• Date Received: 2015-10-13
• Model Number: 96-2151
• Lot Number: 3315274
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: DEPUY/ SYNTHES

Device Sequence Number: 4

• Brand Name: TIBIAL TRAY
• Generic Name: TIBIAL TRAY
• Product Code: HSH
• Date Received: 2015-10-13
• Model Number: 129433160
• Lot Number: 2996074
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: DEPUY/SYNTHES

Device Sequence Number: 5

• Brand Name: FEMORAL COMPONENT
• Generic Name: FEMORAL COMPONENT
• Product Code: HSA
• Date Received: 2015-10-13
• Model Number: 1960-50-500
• Lot Number: 184872
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: DEPUY/SYNTHES

Device Sequence Number: 6

• Brand Name: PATELLA
• Generic Name: PATELLA
• Product Code: HTG
• Date Received: 2015-10-13
• Model Number: 96-0103
• Lot Number: 3426426
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: DEPUY/SYNTHES

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2015-10-13