MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE PRIMARY SHOULDER STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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

It was reported that a hair was found in the plastic wrap of the box.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product identified that there is a hair-like substance between shrink wrap and outer carton.The complaint has been confirmed by visual evaluation.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The product likely left zimmer biomet control non-conforming.The root cause of the reported issue can be attributed to manufacturing deficiency.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.

• Brand Name: COMPREHENSIVE PRIMARY SHOULDER STEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7177905
• MDR Text Key: 97729445
• Report Number: 0001825034-2018-00188
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 113604
• Device Lot Number: 946090
• Other Device ID Number: 0 0880304 55405 4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Date Manufacturer Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1