MAUDE Adverse Event Report: ZIMMER INC MULTIPOLAR BIPOLAR CUP PROVISIONAL LINER; HWT

Catalog Number 00500304022

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that while the surgeon was using a kocher to pull out a liner, the plastic ring on the liner broke.

Manufacturer Narrative

Visual inspection of the returned device confirmed that the locking ring is fractured with a fragment missing.Additional information provided confirmed that this was fractured during the back table assembly, and the fractured fragment was discarded.Review of device history records identified no deviations or anomalies in the manufacturing process.This device was used for treatment.Review of the complaint history indicated no prior complaints associated with the part-lot combination of the returned device.Based on the review of the returned device, a likely cause is normal wear over the course of use.

Manufacturer Narrative

Cracked/fractured-missing ultem locking ring is covered under an index.The device was manufactured prior to corrective action, where the material of the lock ring was changed from ultem to radel.With the information provided, a likely cause for the reported fracture is a previously addressed, design issue.

• Brand Name: MULTIPOLAR BIPOLAR CUP PROVISIONAL LINER
• Type of Device: HWT
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5311783
• MDR Text Key: 34351893
• Report Number: 1822565-2015-02694
• Device Sequence Number: 1
• Product Code: HWT
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00500304022
• Device Lot Number: 61471165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 90 YR