MAUDE Adverse Event Report: ZIMMER INC ZIMMER M/L TAPER FEMORAL STEM; HIP PROSTHESIS

Catalog Number 00771100600

Device Problems Corroded (1131); Noise, Audible (3273)

Patient Problems Pain (1994); Fibrosis (3167); No Code Available (3191)

Event Date 10/16/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to chronic osteomyelitis, benign fibrous synovial tissue with mild chronic inflammation, fibrosis, metallosis, grinding, popping and clicking, pain, impairment, and disfigurement.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: ZIMMER M/L TAPER FEMORAL STEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5555133
• MDR Text Key: 42092392
• Report Number: 1822565-2016-00972
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 00771100600
• Device Lot Number: 60935776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR