MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR PROLONG 36MM BRNG STD; PROSTHESIS, SHOULDER

Catalog Number	110031418
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	04/21/2025
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 closed reduction under sedation approximately 5 months post implantation due to dislocation.The patient had reported pain after undergoing a lumbar kyphoplasty, and an x ray the same day confirmed the dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that a patient underwent a closed reduction under sedation approximately 1.5 years post implantation due to dislocation.The patient had reported pain after undergoing a lumbar kyphoplasty, and an x ray the same day confirmed the 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: b5, d6a.The following sections were updated: b4, 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.Crf records were provided and reviewed by hcp summarizing the following: 2 months postop: patient reported slight pain, no abnormal findings on x-rays.7 months post op: patient tripped and fell, reporting pain, left femoral fracture noted and resolved with surgery.Reduction day: discharge summary after back surgery noted shoulder dislocation.Single ap view demonstrates dislocation of the humeral component lateral and superior to the glenoid component.No definite acute displaced fracture.Closed reduction performed in recovery room.Patient pain resolved.A definitive root cause cannot be determined.The reported event 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: CR PROLONG 36MM BRNG STD
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 22051497
• Report Number: 0001822565-2025-01457
• Device Sequence Number: 21059951
• Product Code: PHX
• UDI-Device Identifier: 00887868231490
• UDI-Public: (01)00887868231490(17)280924(10)65942597
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 09/08/2025

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: Lay User/Patient
• Device Catalogue Number: 110031418
• Device Lot Number: 65942597
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 56 KG