MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL 44-36 STD HMRL BRNG; PROSTHESIS - SHOULDER

Model Number N/A

Device Problems Difficult to Insert (1316); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2014

Event Type  malfunction  

Manufacturer Narrative

Per results relayed by the engineer: several features were found to be out of specification.All of them are likely due to damage of the bearing during the assembly process.Damage to one of the alignment slots (which was likely caused during the assembly process) shows that the bearing was not properly aligned prior to impaction.The locking tab on the bearing has also been damaged during the assembly process.Once the locking tab has been deformed, proper assembly of the components cannot be obtained.The product left biomet conforming.The physical condition of the returned product shows the bearing was not properly positioned during assembly.The complaint of ¿the bearing alignment slots did not line up with the tabs of the humeral tray¿ in unconfirmed.Review of device history records found these units were released to distribution with no deviations or anomalies.Review of complaint history found no additional issues for this part/lot.Device incorrectly prepared for use or modified; inconclusive-root cause cannot be determined; use error caused or contributed to event notified sales rep of completion of investigation.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 a right total shoulder arthroplasty on (b)(6) 2014, the bearing would not lock into the tray.After two attempts, the surgeon was asked to evaluate the setup.At that time, it was revealed that the bearing alignment slots did not line up with the tabs of the humeral tray.A back-up e1 was used without any problems.No further information has been provided.No delay.

• Brand Name: ARCOM XL 44-36 STD HMRL BRNG
• 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: 6914270
• MDR Text Key: 88820525
• Report Number: 0001825034-2017-07898
• 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: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 983100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2014
• 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