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

Catalog Number 00771100520

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It was reported that the implant was presented to the sterile field and subsequently opened.The surgical technologist and sales representative immediately noticed a dark strand, about 1/2 inch long resembling a hair.There was no delay in surgery and surgery was completed with another device.

Manufacturer Narrative

This report will be amended when our investigation is complete.Received, and being evaluated.

Manufacturer Narrative

An m\l taper femoral stem was returned along with the outer packing for review.Visual inspection of the returned device confirms the presence of a hair like dark strand approximately ½ inch in length taped to the top of the foam insert.Follow up with the sales rep revealed that the foreign material was found on the foam insert itself.Follow up with the sales rep also confirmed that everyone in the sterile field were wearing surgical hoods and the hair like strand was observed when the package was opened.The inner packaging was not returned.It was noted that the outer packaging has minor damages likely from opening the packaging and shipping it back.Review of the device history records did not find any deviations or anomalies.This device is used for treatment.Product history search revealed no additional complaints against the related part and lot combination.Since the hair was found on the package after opening, the root cause cannot be definitively determined.

• Brand Name: 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5849875
• MDR Text Key: 51255172
• Report Number: 0001822565-2016-02714
• Device Sequence Number: 1
• Product Code: LZO
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00771100520
• Device Lot Number: 62925422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 49 YR