MAUDE Adverse Event Report: ZIMMER, TURPEAUX INDUSTRIAL PARK BIPOLAR METAL SHELL; KWY

Catalog Number 00500104400

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 11/13/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the locking ring was stuck inside of the groove.An alternate shell was used.

Manufacturer Narrative

The bipolar metal shell was returned for review.The shell has the locking ring stuck in the groove.The locking ring was removed and inspected.It was noted that the locking ring is slightly bent.The dimensions were found conforming to print specifications where measured.This device is used for treatment.Product history search revealed no additional complaints against the related part and lot combination.Step by step assembly instruction and instruction for checking the position and condition of the locking ring prior to assembly are provided both in the multipolar bipolar cup surgical technique and package insert.There is also instruction for checking the position and condition of the locking ring prior to assembly in both the documents.Follow up communication with the field confirms that the issue of the stuck c-ring was identified after attempting to insert the liner.Therefore there is no evidence that the damage was present prior to use.It is likely that the damage to the locking ring happened during the surgical procedure.

• Brand Name: BIPOLAR METAL SHELL
• Type of Device: KWY
• Manufacturer (Section D): ZIMMER, TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5286382
• MDR Text Key: 33260931
• Report Number: 2648920-2015-00425
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00500104400
• Device Lot Number: 62847423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2015
• 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