MAUDE Adverse Event Report: ZIMMER SPINE ARDIS PEEK IMPLANT KIT

Model Number N/A

Device Problems Device Expiration Issue (1216); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 02/04/2016

Event Type  Injury  

Manufacturer Narrative

Based on the information available and through the investigation of this file the implants were labeled correctly and the kit was transferred in between distributorships; the implants were not distributed expired.If additional information is obtained that adds value to the relevant content of this report a follow-up report will be sent.

Event Description

The sales associate reported that the doctor claims there were multiple expired peek implants in the kit he received.Additional product was not readily available during the procedure resulting in unintended size being implanted.The expired implants were not used in the case.The surgeon modified the implant to make it fit.No adverse effects were reported as a result of this event.

• Brand Name: ARDIS PEEK IMPLANT KIT
• Type of Device: ARDIS PEEK IMPLANT KIT
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer (Section G): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer Contact: michelle cole ; 7375 bush lake road; minneapolis, MN 55439 ; 9047414400
• MDR Report Key: 5478518
• MDR Text Key: 39636001
• Report Number: 0002184052-2016-00013
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK133184
• 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
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 32000005PL-014
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR