MAUDE Adverse Event Report: ZIMMER INC TM PRIMARY HIP FEMORAL STEM; LPH

Catalog Number 00786401500

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It is reported the patient was revised due to a fractured femur.

Manufacturer Narrative

This report is being amended to reflect changes in sections.No device or photos were received; therefore the condition of the components is unknown.Review of the device history records did not find any deviations or anomalies.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Product history search revealed no additional complaints against the related part and lot combination.Patient activity level and adherence to rehabilitation protocol are unknown.A definite root cause for the reported issue cannot be determined with the information provided.This device is used for treatment.

• Brand Name: TM PRIMARY HIP FEMORAL STEM
• Type of Device: LPH
• 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: 5324568
• MDR Text Key: 34279199
• Report Number: 1822565-2015-02726
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

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 Catalogue Number: 00786401500
• Device Lot Number: 63014656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2015
• 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