DEPUY TOTAL KNEE REPLACEMENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-26 for DEPUY TOTAL KNEE REPLACEMENT manufactured by Depuy, Johnson & Johnson.

Event Text Entries

[17150265] "first total knee replacement on (b)(6) 2010, endured negative symptoms, constant leg swelling, limping, and pain. Was told it takes a year to heal and went back to the doctor because no improvement in (b)(6) 2012 (b)(6), guessed that medical device (knee component) was broke. Another surgery on same knee done (b)(6) 2012 and i requested possession of the medical device and was shocked to see... " in (b)(6) 2012 i filed grievance with hmo (b)(6), medical record #(b)(4). In (b)(6) 2012, i filed a complaint with the (b)(6) state medical board, case # (b)(4). In (b)(6) 2012, i filed complaint with depuy, johnson & johnsons and forwarded the component to them. Neither acknowledge any fault, compensated me, nor waived hospital co-pay. Had to have a second total knee replacement on the same knee (left) due to broken medical device within 2. 5 years. I feel that no one has acted upon concern for the medical device that broke inside of my knee, knee replacement supposed to have longevity of 12-15 years. I suffered a great deal and met other pts at (b)(4) with same issues.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5031659
• MDR Report Key: 3318750
• Date Received: 2013-08-26
• Date of Report: 2013-08-26
• Date Added to Maude: 2013-09-03
• 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: 0
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: DEPUY TOTAL KNEE REPLACEMENT
• Generic Name: FEMORAL CRUCIATE RETAINING CEMENTED
• Product Code: KRR
• Date Received: 2013-08-26
• Lot Number: 310371-3
• Operator: LAY USER/PATIENT
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY, JOHNSON & JOHNSON

Device Sequence Number: 2

• Brand Name: DEPUY TOTAL KNEE REPLACEMENT
• Generic Name: TIBIAL INSERT FIXED BEARING CURVED
• Product Code: KRO
• Date Received: 2013-08-26
• Lot Number: D09120-042
• Operator: LAY USER/PATIENT
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DEPUY, JOHNSON & JOHNSON

Device Sequence Number: 3

• Brand Name: DEPUY TOTAL KNEE REPLACEMENT
• Generic Name: MODULAR TIBIAL TRAY
• Product Code: HRY
• Date Received: 2013-08-26
• Lot Number: 3015-48-1
• Operator: LAY USER/PATIENT
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: DEPUY, JOHNSON & JOHNSON

Device Sequence Number: 4

• Brand Name: DEPUY TOTAL KNEE REPLACEMENT
• Generic Name: ORAL DOME PATELLA
• Product Code: HTG
• Date Received: 2013-08-26
• Lot Number: 311447-70
• Operator: LAY USER/PATIENT
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: DEPUY, JOHNSON & JOHNSON

Device Sequence Number: 5

• Brand Name: DEPUY TOTAL KNEE REPLACEMENT
• Generic Name: MODULAR CEMENTED STEM
• Product Code: KRO
• Date Received: 2013-08-26
• Lot Number: EESER-4
• Operator: LAY USER/PATIENT
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: DEPUY, JOHNSON & JOHNSON

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Deathisabilit	2013-08-26