MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER M/L TAPER FEMORAL STEM

Catalog Number 00771300700

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 08/15/2014

Event Type  Injury  

Event Description

It is reported that the pt was being revised due to stem loosening.During the revision, the surgeon noticed metallosis.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: ZIMMER M/L TAPER FEMORAL STEM
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4106594
• MDR Text Key: 4763032
• Report Number: 1822565-2014-01111
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2014

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: 06/30/2020
• Device Catalogue Number: 00771300700
• Device Lot Number: 61498044
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VERSYS FEMORAL HEAD, CATALOG #00801803202; KINNECTIV NECK CATALOG # 00784803201,; LOT # 61558178; LOT # 60964081
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 75