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

Catalog Number 65771300900

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Information (3190)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

It is reported that the scrub tech discovered a hair entangled in the plastic pouch of the stem.The surgeon then used a different size stem for the procedure.

Manufacturer Narrative

Eval summary: although foreign material could be introduced during the packaging process, zimmer takes several measures to prevent this from occurring.This device was packaged in a class 10,000 clean room, under a specially designed hooded packaging station that creates a class 1000 clean room environment that significantly reduces the presence of foreign contaminants.Personnel in the clean room are required to wear item such as hair nets, protective clothing and booties, to reduce the likelihood of foreign materials from being introduced during the packaging process.In addition, single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the presence of the hair found in the packaging would have led to any infections or other bio-incompatibility if it had been used.Eval codes: the investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the investigation, the need for corrective action is not indicated.Should add'l substantive info be received, the complaint will be reopened.Zimmer, inc considers the investigation closed.

• Brand Name: ZIMMER M/L TAPER FEMORAL STEM
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46580 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46580-0708 ; 8006136131
• MDR Report Key: 4102510
• MDR Text Key: 4715304
• Report Number: 1822565-2014-01037
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 65771300900
• Device Lot Number: 62564715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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 Age: 64 YR