MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIGHT E-POLY BIAXIAL BRNG KIT; PROSTHESIS, ELBOW, CUSTOM

Catalog Number CP561460

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient is scheduled for an elbow bearing revision to address poly implant wear after more than 10 years implantation.No further information is available at the time of this reporting.

Manufacturer Narrative

No product was returned.Review of device history records found these units were released to distribution with no deviations or anomalies.Root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further information is available at this time.

• Brand Name: TIGHT E-POLY BIAXIAL BRNG KIT
• Type of Device: PROSTHESIS, ELBOW, CUSTOM
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8753804
• MDR Text Key: 149814804
• Report Number: 0001825034-2019-02779
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: CUSTOM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Catalogue Number: CP561460
• Device Lot Number: 020390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other