MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP VRS BONE AND IMP MDL; PROSTHESIS, EXTREMITY, CUSTOM

Catalog Number 110031178

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 02/14/2019

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 was being revised for pain not related to any device failure mode; previous operation did not address the glenoid.It was determined that the lesser tuberosity osteotomy had not healed from the previous surgery.A custom vrs implant was made for the patient.Upon evaluation of the fit of the central pin guide on the patient's native glenoid, it was determined that the fit was grossly unsatisfactory.It was much too large and sloped posteriorly.The surgeon couldn't get an acceptable fit.The surgery was completed with a comprehensive augmented baseplate after a 45 minute surgical delay.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Primary di# (b)(4).Visual examination of the return device finds damage in several spots.The event is not confirmed as the device was delivered manufactured to print.Review of device history records found these units were released to distribution with no deviations or anomalies.Root cause is undetermined.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 available at the time of this reporting.

• Brand Name: COMP VRS BONE AND IMP MDL
• Type of Device: PROSTHESIS, EXTREMITY, CUSTOM
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8347448
• MDR Text Key: 136503521
• Report Number: 0001825034-2019-00678
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: CUSTOM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110031178
• Device Lot Number: 855320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 110027734 VRS GLEN PPS LOT 855290; 110031378 VRS MINI TAPER LOT 855310
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR