MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	115370
Medical Device Problem Codes	Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a shoulder revision approximately nine (9) years and five (5) months post-implantation due to experiencing a humeral tray fracture.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# 180554; lot# 533160, item# 180559; lot# 360740, item# 32-486265; lot# 818770, item# 32-486265; lot# 818560, item# 405800; lot# 687740, item# 405883; lot# 985660, item# 115397; lot# 667560, item# 180552; lot# 096630, item# 115310; lot# 815700, item# 118001; lot# 743970, item# 115330; lot# 790190, item# 180557; lot# 320880, item# 113654; lot# 044360, item# ep-115393; lot# 822020.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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
It was reported that the patient underwent a shoulder revision approximately nine (9) years and five (5) months post-implantation due to experiencing a fracture of the humeral tray's stem/knob.It was noted the patient was exercising when they heard a pop, followed by experiencing pain.It was noted because the humeral tray's knob was fractured off into the humeral stem, the stem also had to be removed, causing the revision to be prolonged 2 hours longer than anticipated.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/corrected: b4; b5; b7; d2; g1; g3; g6; h1; h2; h6.If any further information 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 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/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.Visual examination of the provided photograph identified that the post of the tray has fractured and remains in the revised stem.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.It was noted that the pain and pop occurred while the patient was exercising which could be a contributing factor; however, without additional information on the type of exercise or force experienced, a definitive statement cannot be made.The reported event is confirmed via photographs.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING
• 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: 21960021
• Report Number: 0001825034-2025-01317
• Device Sequence Number: 9188864
• Product Code: PHX
• UDI-Device Identifier: 00880304543201
• UDI-Public: (01)00880304543201(17)250921(10)436370
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2025

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 Expiration Date: 09/21/2025
• Device Catalogue Number: 115370
• Device Lot Number: 436370
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 08/22/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/08/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male