JOHNSON & JOHNSON M SERIES 85-3635

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-24 for JOHNSON & JOHNSON M SERIES 85-3635 manufactured by Depuy Orthopaedics, Inc..

Event Text Entries

[1726767] Painful right total hip with a loose femoral component - cemented stem. Same pt as (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5019143
• MDR Report Key: 1972739
• Date Received: 2011-01-24
• Date of Report: 2011-01-24
• Date of Event: 2002-09-26
• Date Added to Maude: 2011-02-02
• 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
• Reporter Occupation: PATIENT
• Health Professional: 3
• 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: JOHNSON & JOHNSON
• Generic Name: CEMENTED FEMORAL COMPONENT
• Product Code: JDI
• Date Received: 2011-01-24
• Catalog Number: M SERIES 85-3635
• Lot Number: 903381
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY ORTHOPAEDICS, INC.
• Manufacturer Address: 700 ORTHOPAEDIC DR WARSAW IN 46581 US 46581

Device Sequence Number: 2

• Brand Name: DEPUY
• Generic Name: ENDURANCE BONE CEMENT
• Product Code: LOD
• Date Received: 2011-01-24
• Catalog Number: 5450 50 000
• Lot Number: WR6BV4000
• Device Expiration Date: 2005-05-31
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DEPUY ORTHOPAEDICS, INC.
• Manufacturer Address: WARSAW IN 46581 US 46581

Device Sequence Number: 3

• Brand Name: DEPUY
• Generic Name: FEMORAL CEMENT RESTRICTOR
• Product Code: JDK
• Date Received: 2011-01-24
• Catalog Number: 5460 14 000
• Lot Number: WB5B71020
• Device Availability: N
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: DEPUY ORTHOPAEDICS, INC.
• Manufacturer Address: WARSAW IN 46581 US 46581

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2011-01-24