MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr#0001825034-2018-02334.Concomitant medical products: comprehensive reverse humeral tray with locking ring pn115375 ln822570.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, during a reverse shoulder arthroplasty, the locking ring would not engage in the humeral tray.As a result, the surgeon was unable to attach the humeral bearing onto the humeral tray.The procedure was completed by opening a new tray/locking ring.The procedure was no delayed and no impact to the patient was reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.A photo was received; however, it is not possible to determine the condition of the complaint devices from this photo.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 BEARING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7452462
• MDR Text Key: 106260088
• Report Number: 0001825034-2018-02335
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/22/2023
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 699900
• Other Device ID Number: (01) 0 0880304 47542 7
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1