MAUDE Adverse Event Report: ` COMPREHENSIVE REVERSE HUMERAL BEARING TRAY TRIAL; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its whereabouts are currently unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an unknown surgery.During the procedure, as the surgeon was removing the gauge from the patient, the humeral tray broke.The surgery was completed with another device.The patient did not retain any foreign body and no patient impact was reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Examination of the returned device confirms fracture.The post feature was fractured off, however, the stem/post was not returned.Dhr was reviewed and no discrepancies were found.Root cause remains undetermined.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

No further information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of the provided photos which confirms the post has fractured off the back of the trial.Dhr was reviewed and no discrepancies relevant to the reported event 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 was reported that the patient underwent an unknown surgery.During the procedure, as the surgeon was removing the gauge from the patient, the humeral instrument trial broke.The surgery was completed with another device.The patient did not retain any foreign body and no patient impact was reported.

• Brand Name: COMPREHENSIVE REVERSE HUMERAL BEARING TRAY TRIAL
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): `; 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: 7153887
• MDR Text Key: 96126777
• Report Number: 0001825034-2017-11505
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 405940
• Device Lot Number: ZB150402
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2015
• 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