MAUDE Adverse Event Report: ZIMMER, INC. M/L TAPER PRESS-FIT FEMORAL STEM WITH KINECTIV TECHNOLOGY; HIP PROSTHESIS

Catalog Number 00771301000

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that a patient is experiencing pain, loosening, scar tissue and needs to use a cane to walk.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

No device or photos were received since the devices still remain implanted; therefore the condition of the components is unknown.Device history records cannot be reviewed since the part and lot number is unknown.This device was used for treatment.Surgical operative report was provided and some of the portions are not readable; however no complications were noted in the remaining portion of the article.It is stated that the implants gave good stability.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Relevant medical history and adherence to rehabilitation protocol are unknown.A definite root cause cannot be determined with the information provided.

• Brand Name: M/L TAPER PRESS-FIT FEMORAL STEM WITH KINECTIV TECHNOLOGY
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 5689220
• MDR Text Key: 46223982
• Report Number: 0001822565-2016-01849
• Device Sequence Number: 1
• Product Code: LWJ
• 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,Followup
• Report Date: 05/03/2016

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 Catalogue Number: 00771301000
• Device Lot Number: 63076556
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/02/2016; 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• 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: 81 YR
• Patient Weight: 118