MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product-glenoid baseplate catalog#:115330 lot#unk, central screw, catalog#:115381 lot#unk, locking screw catalog#:180502 lot#unk, locking screw, catalog#:180500 lot#unk, locking screw catalog#:180501 lot#unk, locking screw, catalog#:180505 lot#unk, glenosphere catalog#:115316 lot#unk, taper catalog#:118001, lot#unk ,humeral bearing catalog#:xl-115363 lot#unk, reverse shoulder humeral tray, catalog#:115340 lot#257000.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03659.

Event Description

It is reported that during a revision shoulder procedure, the trunnion from a fractured humeral tray was unable to removed, necessitating required removal of the humeral stem.It is unknown how long of a delay to the procedure there was.Attempts have been made, and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4) this follow-up report is being filed to submit additional information.

Event Description

It is reported that during a revision shoulder procedure, the trunnion from a fractured humeral tray was unable to be removed, necessitating required removal of the humeral stem.There was approximately a forty-five (45) to sixty (60) minute delay during the revision surgery to remove the stem.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Manufacturer Narrative

This report is being submitted to relay corrected information.Upon further investigation, it has been determined that this product did not cause or contribute to the reported event.

• Brand Name: COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER STEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6646276
• MDR Text Key: 77720478
• Report Number: 0001825034-2017-03698
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113635
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization; Required Intervention