MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PRX HUM LO PLT RT 11H 190MM; PLATE, FIXATION, BONE

Catalog Number	110030203
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in canada.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 was revised approximately 8 weeks post implantation due to plate fracture.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d9, g3, g6, h2, h11.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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 updated: b4, b5, d6a, g3, g6, h2, h11.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
It was reported that a patient was revised approximately 8 weeks post implantation due to plate fracture.The patient was experiencing pain after the plate fracture.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h11 once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h2, h3, h4, h6, h11.Complaint sample was evaluated, and the reported event was confirmed.The device was returned fractured into two pieces with all pieces being returned.Visual examination of the returned product identified signs of use as well as wear and tear.Measured features of the device to confirm it is conforming to print specifications.The humeral plate surface displayed fracture features in the observed non-smeared regions that suggest a fatigue mode of fracture.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: PRX HUM LO PLT RT 11H 190MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 23803727
• Report Number: 0001825034-2025-03985
• Device Sequence Number: 18465872
• Product Code: HRS
• UDI-Device Identifier: 00887868134579
• UDI-Public: (01)00887868134579(11)230126(10)RM870S
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/24/2026

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 Catalogue Number: 110030203
• Device Lot Number: RM870S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 01/23/2026; 01/28/2026; 04/20/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/17/2025; 01/27/2026; 02/11/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Patient Weight: 91 KG