MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 44-36 STD HMRL BRNG; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the bearing was unable to be implanted.No further information is available at this time.

Manufacturer Narrative

(b)(4).This follow up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: comp rvs tray co 44mm cat: 115370 lot: 638790.Complaint sample was evaluated and the reported event was confirmed.Product was visually examined and dimensional analysis performed.All dimensions checked on the bearing are conforming.There was damage to the bearing in the extraction hole.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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: E1 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: 7142760
• MDR Text Key: 95794774
• Report Number: 0001825034-2017-11254
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK113121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/06/2022
• Device Model Number: N/A
• Device Catalogue Number: EP-115393
• Device Lot Number: 024880
• Other Device ID Number: (01) 0 0880304 54315 7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• 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: 75 YR