MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL REVERSE SHOULDER SYSTEM POLY LINER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	00434903600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Bone Notching (4890)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item#: 115310; lot#: j7292125.G2: foreign - event occurred in australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.The investigation is in process.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 primary shoulder arthroplasty on approximately two (2) years and eight (8) months ago.Subsequently, the patient complained of discomfort and upon assessment, the patient was notching.The patient then underwent a revision surgery approximately one (1) month ago where the surgeon removed a section of proximal gt and bone spurs on the scapula.The surgeon opted to lateralise and increase the offset on the glenosphere to avoid notching and rom restriction/discomfort.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.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 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a reverse-type right shoulder arthroplasty is anatomically aligned.There is no fracture or implant loosening.There is a prominent greater tuberosity and mild prominence of the undersurface of the acromion.There is no evidence of scapular notching.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The complaint is unable to be confirmed.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.

• Brand Name: TRABECULAR METAL REVERSE SHOULDER SYSTEM POLY LINER
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 22186401
• Report Number: 0001822565-2025-01855
• Device Sequence Number: 12904233
• Product Code: PHX
• UDI-Device Identifier: 00889024269057
• UDI-Public: (01)00889024269057(17)290223(10)64812469
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 09/22/2025

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: Lay User/Patient
• Device Catalogue Number: 00434903600
• Device Lot Number: 64812469
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 09/17/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 06/18/2025; 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Male