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

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.This report will be amended when our investigation is complete.

Event Description

It is reported that the patient's hip arthroplasty was revised due to elevated cobalt levels, pain and a pseudo tumor.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable as this component did not cause serious injury.

• Brand Name: UNKNOWN ZIMMER M/L TAPER FEMORAL STEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6088752
• MDR Text Key: 59454718
• Report Number: 0001822565-2016-04126
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 81