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

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: screw catalog#: 115383 lot#: 552680, screw catalog#: 180500 lot#: 836390, screw catalog#: 180500 lot#: 669780, screw catalog#: 180501 lot#: 730570, screw catalog#: 180502 lot#: 605670, glenosphere catalog#: 115320, lot#: 890140, pin catalog#: 405800 lot#: 914650, drill catalog#: 405889 lot#: 209110, drill catalog#: 405883 lot#: 316690, taper catalog#: 118001 lot#: 927470, baseplate catalog#: 115330 lot#: 926700, bearing catalog#: xl-115366 lot#: 585890, extract catalog#: 110028441 lot#: unk, tray catalog#: 115340 lot#: 983880.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: 0001825034-2017-04550, 0001825034-2017-04590.

Event Description

It is reported that during a reverse total shoulder arthroplasty revision procedure, the taper from the fractured humeral tray was stuck in the stem and the removal tool was not able to remove it after several attempts.As a result, it became necessary to remove the humeral stem.During stem removal, the stem extractor instrument fractured.The surgery was completed by using a small drill bit to remove bone from the proximal end of the stem and used vice grips to remove the stem.A new stem of the same size and a +5 bearing and new tray were implanted to complete the procedure.This malfunction ended up causing an approximate delay of thirty five (35) to forty five (45) minutes in the procedure.

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: 6691631
• MDR Text Key: 79227173
• Report Number: 0001825034-2017-04588
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 113631
• Device Lot Number: 423170
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2011
• 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
• Patient Age: 66 YR