MAUDE Adverse Event Report: ZIMMER, INC. PERSONA VIVACITE HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACE; OIY

Model Number N/A

Device Problems Difficult to Insert (1316); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the articular surface implant did not seat properly.Another device was used to complete the surgery.

Manufacturer Narrative

Visual inspection of the returned part revealed significant gouges located on the insertion/extraction slot on the anterior portion of the distil surface.The device history records were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.Dimensions are within specifications as documented in the print.This device is used for treatment.It is unknown if the procedure for the initial seating of the part was executed correctly.The product history search for the part and lot combination identified no other complaints related to the part lot.Based on the investigation findings and the information provided, no product issue could be identified.

• Brand Name: PERSONA VIVACITE HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACE
• Type of Device: OIY
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): .; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5646378
• MDR Text Key: 45002929
• Report Number: 0001822565-2016-01527
• Device Sequence Number: 1
• Product Code: OIY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 42522400510
• Device Lot Number: 62570484
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• 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