MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. MULTIPOLAR BIPOLAR CUP LINER

Catalog Number 00500104226

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2014

Event Type  malfunction  

Event Description

It is reported that after the surgeon inserted the head into the liner, then the liner into the shell, the liner sat proud 15-20 mm.The surgeon said he couldn't get the locking ring to engage.A new head, liner, and shell were opened and implanted.

Manufacturer Narrative

Evaluation summary: when both tabs are not in the slot, the locking ring will not expand adequately to accept the liner.This can result in difficulty to insert the liner into the bipolar metal shell.Step by step assembly instruction is provided both in the surgical technique and package insert.Also, there is instruction for checking the position and condition of the locking ring prior to assembly.Cause cannot be definitively determined.Evaluation: visual examination of the returned poly liner determined that it was deformed and seized in the shell.One of two tabs of the locking ring is bent.The metal ring migrated from its intended positon and is seized on one side of the locking ring groove.Dimensional readings of the shell and locking ring conform to print specifications.The poly liner exhibits damage too severe for dimensional analysis.No manufacturing abnormalities could be detected.

• Brand Name: MULTIPOLAR BIPOLAR CUP LINER
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4347383
• MDR Text Key: 5140117
• Report Number: 2648920-2014-00382
• 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: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Catalogue Number: 00500104226
• Device Lot Number: 62640304
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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
• Treatment: MULTIPOLAR BIPOLAR CUP SHELL, CATALOG #0050010430; LOT #62618913