MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM ÿ +6MM OFFSET POLY LINER; SHOULDER, PROSTHESIS

Catalog Number 00434903606

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported that the patient was revised due to dislocation.The bearing was removed and replaced approximately four years post implantation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-01112.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 +6MM OFFSET POLY LINER
• Type of Device: SHOULDER, PROSTHESIS
• 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: 19018495
• MDR Text Key: 339092642
• Report Number: 0001822565-2024-01111
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024269071
• UDI-Public: (01)00889024269071(17)270930(10)64333482
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2024

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 Catalogue Number: 00434903606
• Device Lot Number: 64333482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/02/2024
• Date Device Manufactured: 09/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN GLENOSPHERE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male