MAUDE Adverse Event Report: ZIMMER INC ZIMMER M/L TAPER FEMORAL STEM; LZO

Catalog Number 00771301500

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 01/25/2016

Event Type  Injury  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient fell and broke his femur after a total hip replacement that was performed on (b)(6) 2015.The stem was loose and needed to be replaced to a long stem that would provide distal fixation.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Updated 510(k): k063251.No device was returned; the photograph of the explanted devices are intact and do not show signs of significant wear.Dhr review shows no deviations or anomalies in the manufacturing process.The reported devices are used for treatment.Review of the complaint history identified no additional complaints for the part and lot combination.It was confirmed that the device was used in an approved and compatible combination.Returned operative notes state that the original hip implant surgery was performed without complication.Patient is stated to have a high activity level.Adherence to rehabilitation protocol is not known.Patient is stated to have excellent bone quality.X-rays were reviewed during a follow up visit, and a periprosthetic proximal femur fracture was noted that has led to implant loosening.There is also a small piece of bone around the tibial tubercle.Patient fell on their right knee, and their healthcare professional states they suffered a patella tendon tear.They did not complaint of pain in the hip, however pain was stated to be severe with range of motion.With the information presented, the root cause for the reported periprosthetic fracture is due to patient injury from falling.

• Brand Name: ZIMMER M/L TAPER FEMORAL 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: 5441866
• MDR Text Key: 38360438
• Report Number: 1822565-2016-00315
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063251
• 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: 01/12/2017

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 00771301500
• Device Lot Number: 62560137
• Other Device ID Number: 1240077130150012336562560137A1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2014
• 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: 54 YR
• Patient Weight: 102