MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unintended System Motion (1430)

Patient Problem Tissue Damage (2104)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: (b)(4).Concomitant medical products: 00434901013, humeral stem 10 mm stem diameter 130 mm stem length, lot 61966843; 00434903909, humeral stem spacer size 9, lot 61994540; 00434903611, glenosphere 36 mm diameter, lot 61955402; 00434903811, base plate uncemented, lot 61990797.

Event Description

It was reported that approximately five (5) years post implantation of a reverse total shoulder arthroplasty, the patient had developed grade 4 scapular notching, found on radiograph.There has been no medical intervention as of now.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were update/corrected updated: reported event was confirmed by review of radiographs.X-rays showed grade 4 scapular notching above the inferior screw.There was no evidence of lucency or component shift to the glenoid or humeral components.There was also some inferior glenoid bone formation.Device history record (dhr) was reviewed and no discrepancies were found.A definite root cause cannot be determined with the information 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

No further event information available at the time of this report.

• Brand Name: TM REVERSE POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 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: 8064738
• MDR Text Key: 126946481
• Report Number: 0001822565-2018-06310
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052906
• 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: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00434903600
• Device Lot Number: 61910777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2011
• 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): Other
• Patient Weight: 82