MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 44-36 STD +3 HMRL BRG; PROTHESIS, SHOULDER

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant products: 115375 comp rvs tray +5mm co 44mm 029050; 106021 ringloc+ replacement ring sz21 772120.Complaint sample was evaluated and the reported event was confirmed.Visual inspection revealed locking ring was severely bent and dinged; tray taper scratched; and poly had slight nicks and scratches.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.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.

Event Description

It is reported that during initial reverse shoulder surgery, the poly was not able to assemble with the tray.Even after trying to use a new locking ring with the poly, still it wont assemble with the tray.Attempts have been made and additional information is not available at this time.

• Brand Name: E1 44-36 STD +3 HMRL BRG
• Type of Device: PROTHESIS, 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: 7324631
• MDR Text Key: 101996301
• Report Number: 0001825034-2018-01790
• 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
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2021
• Device Model Number: N/A
• Device Catalogue Number: EP-115394
• Device Lot Number: 633410
• Other Device ID Number: (01)00880304543188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2016
• 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: 59 YR
• Patient Weight: 127