MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVSR SHLDR GLNSP +3 36MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	115313
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a shoulder arthroscopy.Subsequently, the patient was revised due to dislocation.There was harm/injury to the patient as the patient had to underwent additional surgical/medical intervention.Due diligence is complete.No additional information is available.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under: (b)(4).G2: country event occurred in: australia.D10 narrative: item: unknown humeral bearing.Lot: unknown.H6: component code: proposed code: mechanical (g04)- head.The product will not be evaluated by zimmer biomet as it was not returned by the hospital.Once the investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 2 months post implantation due to dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were corrected: b1, b5 the following sections were updated: b4, g3, g6, h2, h3, h6, h11 visual examination of the provided pictures identified the explanted products with biological debris on them.However, as the products were not returned, further analysis could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.It was indicated that additional glenoid bone removal was necessary on revision of the products.This was not completed on the initial procedure due to previous bone fracture.It is unknown if the incomplete bone removal in the initial procedure contributed to the dislocation.As such, a definitive root cause cannot be determined.The reported event is unable to be confirmed.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: COMP RVSR SHLDR GLNSP +3 36MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 22077307
• Report Number: 0001825034-2025-01489
• Device Sequence Number: 9363578
• Product Code: PHX
• UDI-Device Identifier: 00880304475779
• UDI-Public: (01)00880304475779(17)340723(10)J7804526
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193373
• 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
• Report Date (Section B): 06/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 115313
• Device Lot Number: J7804526
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown