MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS TRAY CO 44MM; PROSTHESIS, SHOULDER

Catalog Number	115370
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that a patient underwent a revision procedure approximately 9 years post implantation due to implant fracture.Prior to the revision, it was noted that the patient was experiencing pain and rom issues.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Visual examination of the provided pictures identified the post of the tray fractured.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single ap view of the left shoulder demonstrates a reverse total shoulder arthroplasty with no dislocation.Inferiorly directed glenosphere, nonspecific.Question lucency along the proximal humeral component could indicate loosening.Vertically oriented humeral tray could indicate hardware fracture.A definitive root cause cannot be determined.The reported event is confirmed as a picture was provided.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 or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMP RVS TRAY CO 44MM
• Common Device Name: 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: 19509351
• Report Number: 0001825034-2024-01539
• Device Sequence Number: 12618427
• Product Code: PHX
• UDI-Device Identifier: 00880304543201
• UDI-Public: (01)00880304543201(17)250429(10)892680
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/29/2025
• Device Catalogue Number: 115370
• Device Lot Number: 892680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male