MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Bent (1059); Difficult To Position (1467)

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

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) there were multiple reports submitted for this event: mfr# 0001825034-2018-00291.Concomitant medical products: comprehensive reverse e1 humeral bearing pnep-115393 ln320400.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a reverse total shoulder arthroplasty.During the procedure, it was noticed that the locking ring would not hold the poly as it appeared to be bent.The deformation was observed as the surgeon was putting the poly into the humeral tray.The surgery was completed using another humeral tray.There was no surgical delay.No patient impact was reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection revealed ringloc was bent within the tray.Visual inspection of the humeral tray indicates it is conforming to the print, except for the bend.There are no burrs or obstructions in the tray¿s ringloc groove.Dimensional inspections reveals measurements are within specifications.Device history record (dhr) was reviewed and no discrepancies were found relevant to the reported event.Root cause of the event 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.

• Brand Name: COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7238402
• MDR Text Key: 99092085
• Report Number: 0001825034-2018-00290
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK113069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• 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: 115370
• Device Lot Number: 060730
• Other Device ID Number: (01) 0 0880304 54320 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2017
• 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
• Patient Age: 77 YR