MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER MEDIUM UNCEMENTED AUGMENTED BASEPLATE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110032420
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported a patient had an initial shoulder arthroplasty.The surgeon expressed concern after the case that the baseplate was implanted 180 degrees opposite of his planned and prepped location.The surgeon plans to remove and replace the baseplate; however, no further intervention has been reported to date.Attempts have been made, and no further information has been provided.
Event or Problem Description
It was reported a patient had an initial shoulder arthroplasty.The surgeon expressed concern after the case that the baseplate was implanted 180 degrees opposite of his planned and prepped location.The patient was revised the following day.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d6b; g1; g3; g6; h1; h2 if any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b2; b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6.The reported event cannot be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.The provided radiographs were not sent for further evaluation as 180 degree rotation of the intended implant orientation and preparation cannot be confirmed in the single orientation provided.The root cause of the reported issue is attributed to user error.The baseplate cannot be placed in the incorrect orientation when the surgical technique is followed.Per surgical technique "position the alignment post of the baseplate impactor so it engages in the 2.7 mm alignment hole on the glenoid, which is directly opposite of the bone prepared for the augment).When the alignment post is in the correct orientation, the half circle etch and augment label on the inserter should match the glenoid bone prepared for the augmented aspect of the baseplate." if any further information is found 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 is available at the time of this report.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER MEDIUM UNCEMENTED AUGMENTED BASEPLATE
• 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: 23031859
• Report Number: 0001825034-2025-02891
• Device Sequence Number: 9491493
• Product Code: PHX
• UDI-Device Identifier: 00880304993242
• UDI-Public: (01)00880304993242(17)300615(10)67246603
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K172502
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2026

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: 110032420
• Device Lot Number: 67246603
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 02/13/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 01/20/2026; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2025
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male