MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL REVERSE PLUS; REVERSE SHOULDER PROSTHESIS BASE PLATE

Catalog Number	00436202000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The product will not be evaluated by zimmer biomet as it remains implanted in the patient.Once the investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported that the patient underwent shoulder arthroplasty.Subsequently, the patient returned to clinic for evaluation due to pain.Imaging confirmed a stress fracture lateral to the glenoid.Patient wore a sling for four weeks to immobilize the joint and also received additional physical therapy.The event was reported to be resolved.Approximately one-year post-implantation, the patient was noted to have slight pain and slight difficulty with activities.No further intervention has been reported to date.Due diligence is progress.No additional information is available at this time.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, e1, e2, e3, g1, g3, g6, h2, h6, h11.H6 component codes: proposed annex g code: mechanical (g04) - head.The product will not be evaluated by zimmer biomet as it remains implanted in the patient.Once the investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
No additional information is available regarding the incident.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were corrected: d1, d2, d4, e1, h4, h6.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.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.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 10 months post op, subject returned to clinic due to shoulder pain.An mri demonstrated a stress fracture in the bone lateral to the glenoid.11 months post op, x-rays demonstrated displaced acromial stress fracture, patient wore sling and began physical therapy.1 year post op, patient returns for follow-up, pain has been well controlled.Xrays demonstrate a stable right reverse total shoulder arthroplasty with a displaced but stable acromial stress fracture.Plan to continue routine post-op rehab and activities as tolerated, will follow-up in 3 months for additional imaging.A definitive root cause cannot be determined.The reported event is confirmed by provided medical records.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: TRABECULAR METAL REVERSE PLUS
• Common Device Name: REVERSE SHOULDER PROSTHESIS BASE PLATE
• 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: 21531871
• Report Number: 0001822565-2025-00543
• Device Sequence Number: 17906156
• Product Code: PHX
• UDI-Device Identifier: 00889024489448
• UDI-Public: (01)00889024489448(17)331015(10)65175005
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K172767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 00436202000
• Device Lot Number: 66175005
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 03/17/2025; 05/30/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/28/2025; 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 96 KG