MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM ÿ GLENOSPHERE; PROSTHESIS, SHOULDER

Catalog Number 00434903611

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: +2mm lateral offset 25mm post length base plate, cat# 00434902502, lot# 64759470; 9mm humeral stem spacer, cat# 00434903909, lot# 65171976; 36mm +0mm offset poly liner, cat# 00434903600, lot# 64737398; 10mm 130mm length humeral stem, cat# 00434901013, lot# 64986610.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 - 02505, 0001822565 - 2022 - 02506, 0001822565 - 2022 - 02507, 0001822565 - 2022 - 02508.

Event Description

It was reported that a patient is experiencing pain after the implantation of a primary shoulder approximately 6 months ago.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

H6 component code: mechanical (g04) ¿ head.No product 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.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.

• Brand Name: 36MM ÿ GLENOSPHERE
• 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: 15347848
• MDR Text Key: 299160906
• Report Number: 0001822565-2022-02503
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 0889024269088
• UDI-Public: (01)0889024269088(17)300916(10)64844912
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00434903611
• Device Lot Number: 64844912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• 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): Other
• Patient Sex: Male