MAUDE Adverse Event Report: ZIMMER, INC. VIVACIT-E CROSSLINKED POLYETHYLENE ELEVATED RIM LINER; OQI

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the liner couldn't be assembled into the cup.

Manufacturer Narrative

This report is being amended to reflect changes in sections.Received, not yet evaluated.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

An elevated rim liner was returned for evaluation.As returned, the locking features exhibit damage.The device history record (dhr) review shows that the surface profile of anti-rotation features, od spherical radius, locking features, and taper are 100% inspected at the time of manufacture.Inspection documentation shows all devices that were accepted, completed, and sent to inventory met specifications.The shell was not returned because it remains implanted, therefore, no physical evaluation could be conducted.The dhrs were reviewed and indicate the devices were manufactured to specifications, with no anomalies or deviations that would have affected the surgical outcome or contributed to the reported event.These devices are used for treatment.Complaint history searches found there are no additional complaints for the product part/lot combinations involved.Due to the shell remaining implanted and unable to evaluate, a specific cause for the reported condition could not be determined with certainty.

• Brand Name: VIVACIT-E CROSSLINKED POLYETHYLENE ELEVATED RIM LINER
• Type of Device: OQI
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5659426
• MDR Text Key: 45302226
• Report Number: 0001822565-2016-01596
• Device Sequence Number: 1
• Product Code: OQI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00885201032
• Device Lot Number: 62913187
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1