CENTRALIZER * 1376-21-000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-26 for CENTRALIZER * 1376-21-000 manufactured by Depuy Orthopaedics, Inc..

Event Text Entries

[16475098] A hip implant was removed from a pt. The implant was explanted due to the pt's complaint of constant pain. The culture revealed burkholderia picketii, a gram negative closely related to the pseudomonas family. The device is being returned to mfr to facilitate investigation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4002785
• MDR Report Key: 280582
• Date Received: 2000-05-26
• Date of Report: 2000-05-25
• Date of Event: 1997-05-02
• Date Added to Maude: 2000-06-07
• 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
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CENTRALIZER
• Generic Name: ALIGNMENT INSERT 12.0MM INSERT
• Product Code: IQO
• Date Received: 2000-05-26
• Returned To Mfg: 2000-05-26
• Model Number: *
• Catalog Number: 1376-21-000
• Lot Number: 552390035
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 271537
• Manufacturer: DEPUY ORTHOPAEDICS, INC.
• Manufacturer Address: P.O. BOX 988 WARSAW IN 465810988 US

Device Sequence Number: 2

• Brand Name: MODULAR CATHCART FRACTURE HEAD TAPERED SPACER
• Generic Name: LARGE TAPER +10MM
• Product Code: HSA
• Date Received: 2000-05-26
• Returned To Mfg: 2000-05-26
• Model Number: *
• Catalog Number: 1363-22-000
• Lot Number: 564240028
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 271543
• Manufacturer: DEPUY ORTHOPAEDICS, INC.
• Manufacturer Address: P.O. BOX 988 WARSAW IN 465810988 US

Device Sequence Number: 3

• Brand Name: RESPONSE 209 HIP SYSTEM
• Generic Name: HIP 12.00 MM DIAMETER 140 MM LENGTH NARROW
• Product Code: JDI
• Date Received: 2000-05-26
• Returned To Mfg: 2000-05-26
• Model Number: *
• Catalog Number: 1363-92-000
• Lot Number: RJ8CE1001
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 3
• Device Event Key: 271545
• Manufacturer: DEPUY ORTHOPAEDICS, INC.
• Manufacturer Address: P.O. BOX 988 WARSAW IN 465810988 US

Device Sequence Number: 4

• Brand Name: MODULAR CATHCART FRACTURE HEAD
• Generic Name: HIP BALL
• Product Code: KWY
• Date Received: 2000-05-26
• Returned To Mfg: 2000-05-26
• Model Number: *
• Catalog Number: 1363-58-000
• Lot Number: 806340027
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 4
• Device Event Key: 271549
• Manufacturer: DEPUY ORTHOPAEDICS, INC.
• Manufacturer Address: P.O. BOX 988 WARSAW IN 465810988 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit	2000-05-26