MAUDE Adverse Event Report: ZIMMER, INC. UNK ZIMMER FEMORAL STEM; HIP PROSTHESIS

Device Problems Failure To Adhere Or Bond (1031); Corroded (1131)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 11/27/2013

Event Type  Injury  

Event Description

It is reported that the pt was revised due to pain, high cobalt chrome levels, loosening, difficulty walking and an occasional rash.Corrosion was noted on the stem's trunnion.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: UNK ZIMMER FEMORAL STEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4256160
• MDR Text Key: 5047385
• Report Number: 1822565-2014-01555
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2014
• Initial Date FDA Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR