MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACROM XL 44-41 STD +3 HMRL BRG; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

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

Event Date 12/04/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results of the per relayed by the engineer: product was as found within design specifications.Product was returned in assembled condition with no apparent nonconformance.Dhr was reviewed and no discrepancies relevant to the reported event were found 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 during an initial right shoulder procedure, that the humeral insert was properly placed into humeral tray, but when the tech went to check the bearing, it was noticed that there was an excessive amount of motion.The bearing had not locked properly in the humeral tray.The insert was removed and retried, with the same result.The surgeon used another tray and bearing to complete the procedure.

• Brand Name: ACROM XL 44-41 STD +3 HMRL BRG
• 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: 6912521
• MDR Text Key: 88240330
• Report Number: 0001825034-2017-07710
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• 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
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: N/A
• Device Catalogue Number: XL-115367
• Device Lot Number: 350700
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2010
• 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