MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSI SHOULDER TM GLENOID LT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 20-8075-004-01

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 11/29/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a revision six(6) years post implantation due disassociation and pain.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 118001; lot# 139970.Item# 113032; lot# 214780.Item# 113610; lot# 115800.Item#00-4326-040-46; lot#62700439.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would d change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This medwatch is to void previously submitted medwatch, mdr329785, as it was reported incorrectly under warsaw zimmer and a correction report will be sent for the correct location.

Event Description

This medwatch is to void previously submitted medwatch, mdr329785, as it was reported incorrectly under warsaw zimmer and a correction report will be sent for the correct location.

• Brand Name: PSI SHOULDER TM GLENOID LT
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 16021752
• MDR Text Key: 305874338
• Report Number: 0001822565-2022-03555
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2016
• Device Catalogue Number: 20-8075-004-01
• Device Lot Number: 63178536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 11/26/2022
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• 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): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female