MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR VRS GLEN PPS MIN TPR ADR; PROSTHESIS, SHOULDER

Catalog Number 110027734

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that a patient underwent an initial right shoulder arthroplasty approximately 2 years ago and is being considered for a revision due to loosening and pain.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: COMPR VRS GLEN PPS MIN TPR ADR
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19213312
• MDR Text Key: 341391590
• Report Number: 0001825034-2024-01102
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304818934
• UDI-Public: (01)00880304818934(17)220910(10)714690
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202232
• 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: 04/30/2024

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 Expiration Date: 09/10/2022
• Device Catalogue Number: 110027734
• Device Lot Number: 714690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2022
• 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
• Patient Outcome(s): Other
• Patient Sex: Male