MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 15MM POST LENGTH BASE PLATE; PROSTHESIS, SHOULDER

Catalog Number 00434901500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problem Erosion (1750)

Event Date 12/05/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a revision procedure approximately 2.5 years post implantation due to liner disassociation.During the procedure, scapular notching was noted as well as a deformed liner locking mechanism.The poly liner, spacer, and glenosphere were exchanged.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: 40mm poly liner + 3mm 65deg, cat# 00434906603, lot# 64374987.12mm humeral stem spacer, cat# 00434903912, lot# 62952482.40mm glenosphere cat# 00434904011, lot# 64503726.Report source: canada.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 03571, 0001822565 - 2022 - 03572, 0001822565 - 2023 - 00380.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No baseplate was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a reverse-type left shoulder arthroplasty is present with glenohumeral dislocation.There is no fracture or evidence of implant loosening.Bone quality appears osteopenic.A definitive root cause cannot be determined.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 is available at the time of this report.

• Brand Name: 15MM POST LENGTH BASE PLATE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16375247
• MDR Text Key: 309525449
• Report Number: 0001822565-2023-00379
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 00889024268999
• UDI-Public: (01)00889024268999(17)290630(10)64428911
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00434901500
• Device Lot Number: 64428911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male