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

Catalog Number EP-115393

Device Problem Difficult to Insert (1316)

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

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) multiple mdr's were filed in association with this event: please see: 0001825034-2019-02202.Primary di# 00880304543157.Report source foreign: the event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported the had difficulty fulling locking the insert into the humeral tray, but was eventually successful after several further impaction blows.No delay to surgery or adverse consequences to the patient were reported.No further information has been made available at this time.

Event Description

No further information available at the time of this reporting.

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.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: E1 44-36 STD HMRL BRNG
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8662596
• MDR Text Key: 148186044
• Report Number: 0001825034-2019-02203
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: K113121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2024
• Device Catalogue Number: EP-115393
• Device Lot Number: 640960
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 115370 LOT 270210 HUMERAL TRAY STANDARD
• Patient Age: 72 YR