MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X15 ST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	180550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient passed away in recovery following a reverse total shoulder replacement with the comprehensive system.As far as the surgeon was concerned, the operation was completed as expected.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in australia.D10: concomitant medical products, part (lot): 115310(j7836529), 110032410(67185082), 115395(66792976), 180552(66890490), 180553(67271033), 180550(67338919), 113613(66840669).Associated product information: 110031424(67233121), 110031399(67351423).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.The customer has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6.The reported event is not confirmed.Product has not been returned.No product evaluation was able to be completed.Procedural related complications are influenced by the type of surgery, patient's pre-existing health conditions and perioperative management.In this case the patient expired after a successful surgery in the postoperative area.Cause of death has not been provided and no additional information concerning patient preoperative health history has been provided.Any surgical procedure under anesthesia places the patient at risk for bleeding, dvt/pe, cardiac stress, stroke, malignant hyperthermia and blood pressure irregularities all of which could contribute to a patient having severe complications and even death.As this is not related to our products or instrumentation, we would not consider this device related, but related to the procedure.Root cause of the reported event is not device related.If any further information is found that 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 LK SCR 3.5HEX 4.75X15 ST
• 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: 22530377
• Report Number: 0001825034-2025-02160
• Device Sequence Number: 18125707
• Product Code: PHX
• UDI-Device Identifier: 00880304677135
• UDI-Public: (01)00880304677135(17)350430(10)67338919
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 11/13/2025

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: 180550
• Device Lot Number: 67338919
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Death
• Patient Age: 66 YR
• Patient Sex: Male