MAUDE Adverse Event Report: ZIMMER, TURPEAUX INDUSTRIAL PARK MULTIPOLAR BIPOLAR CUP; KWY

Catalog Number 00500105400

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2015

Event Type  malfunction  

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 implant was pulled from packaging during surgery and found a malfunction on the locking ring.Prong embedded in the ring groove.

Manufacturer Narrative

Visual examination of the returned bipolar cup confirmed the metal ring was returned assembled and would not move freely within the window.Dimensional evaluation of the cup and metal ring verified that these conformed to print specifications where measured.The metal ring was bent and had damage indicative of impaction of the ring.It was confirmed that attempts to assemble the liner were performed on the back table.Device history record review indicated no deviations or anomalies in the manufacturing process.This reported device is used for treatment.Review of complaint history identified no previous complaints for the part-lot combination associated with the cup.When both tabs are not in the slot, the locking ring will not expand adequately to accept the liner.This can result in, as described in this complaint, difficulty to insert the liner into the bipolar metal shell.With the information provided a likely cause for the reported issue is user not adhering to the instructions provided in the surgical technique.

• Brand Name: MULTIPOLAR BIPOLAR CUP
• Type of Device: KWY
• Manufacturer (Section D): ZIMMER, TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer (Section G): 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: 5157697
• MDR Text Key: 28843852
• Report Number: 2648920-2015-00377
• 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: distributor,health profession
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: 00500105400
• Device Lot Number: 62826995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2014
• 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 Age: 58 YR