MAUDE Adverse Event Report: ZIMMER INC ZIMMER M/L FEMORAL PRESS-FIT STEM; LZO

Catalog Number 65771102000

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 03/17/2016

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 pain and loosening of the stem.During the implantation surgery, the surgeon was informed that the prosthesis implanted may not be of the appropriate size.

Manufacturer Narrative

This report is being amended to reflect changes in date received by mfr, type of reports, if follow-up, what type?, evaluation codes, and additional mfr narrative.No device or photos were received, therefore the condition of the device is unknown.Review of device history records identified no deviations or anomalies in the manufacturing process.This device is used for treatment.Review of complaint history for the part-lot combination of the reported device identified no additional complaints.It could not be confirmed if the device was used in an approved and compatible combination.Surgical notes were not provided.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.Follow up was performed to confirm if surgical technique or the reported ineffectual templating contributed to the reported event, however no additional information was provided.A definitive root cause cannot be determined with the information provided.

• Brand Name: ZIMMER M/L FEMORAL PRESS-FIT STEM
• Type of Device: LZO
• 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: 5563931
• MDR Text Key: 42266791
• Report Number: 1822565-2016-00983
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 65771102000
• Device Lot Number: 60649795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2007
• 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
• Patient Weight: 59