MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING 44MM STANDARD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); No Information (3190)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It is reported that the patient underwent a shoulder arthroplasty revision approximately seven (7) years post-operatively due to humeral tray fracture.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant 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.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2017-03698.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 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 follow-up report is being submitted to relay additional information.Concomitant medical product-baseplate catalog#: 115330 lot#: 256930, central screw catalog#: 115381 lot#: 468470, locking screw catalog#: 180502 lot#: 468590, locking screw catalog#: 180500 lot#: 029310, locking screw catalog#: 180501 lot#: 851500, locking screw catalog#: 180505 lot#: 003210, glenosphere catalog#: 115316 lot#: 742390.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Previous investigation into this device/issue determined that the root cause is related to the design of the device.This device is in scope of previously initiated corrective action.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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 follow up report was created upon receipt of additional information.

Event Description

It is reported that the patient underwent an initial right reverse total shoulder arthroplasty as well as right shoulder major structural bone grafting to superior glenoid.Approximately 7 years after, the patient was revised due to the humeral tray fracturing.

Manufacturer Narrative

Reported event was confirmed by review of revision operative notes.Root cause remains unchanged.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 the patient underwent an initial right reverse total shoulder arthroplasty as well as right shoulder major structural bone grafting to superior glenoid.Approximately 7 years after, the patient was revised due to the humeral tray fracturing at the junction between the trunnion and the humeral tray.The patient was also experiencing pain due to the component fracture.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product shows wear and damage to the humeral bearing.The tray stem is fractured and not returned.The tray has some noticeable wear and damage to the bottom of the tray.This humeral tray fracture is a known issue and has been addressed.Root cause is attributed to design of the device.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: COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING 44MM STANDARD
• 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: 6608640
• MDR Text Key: 76542649
• Report Number: 0001825034-2017-03571
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 257000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1103-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR