MAUDE Adverse Event Report: ZIMMER MULTIPOLAR BIPOLAR LINER

Catalog Number 00500104428

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/07/2014

Event Type  malfunction  

Event Description

It is reported that the bipolar shell, liner and head were opened on the field and assembled, and then before implanting a hair was found on the liner.A different construct was implanted.The operating staff did not use helmets.

Manufacturer Narrative

Eval summary: helmets are not used during surgery; therefore the operating staff is one potential source of the hair.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 items 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.Cause cannot be definitively determined.Eval codes: the device was returned, and no foreign material or hair is seen.No mfg abnormalities could be detected.

• Brand Name: MULTIPOLAR BIPOLAR LINER
• Manufacturer (Section D): ZIMMER; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4412307
• MDR Text Key: 5377121
• Report Number: 2648920-2015-00006
• Device Sequence Number: 1
• Product Code: KWY
• 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: 12/12/2014

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: 06/26/2021
• Device Catalogue Number: 00500104428
• Device Lot Number: 62406825
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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: 84 YR