MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 15MM POST LENGTH BASE PLATE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	00434901500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Bone Notching (4890)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).B3: unknown date in (b)(6) 2024.Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part (lot): -00434903611(63934555) associated product information, part (lot): -00434903603(63842343) -00434901213(63867902) the reported event is confirmed through evaluation of medical records.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.X-rays were provided and reviewed by a health care professional.Review of the available records identified the following: there is a reverse total shoulder arthroplasty in place with non-cemented humeral component.There is deep scapular notching that extends to the inferior baseplate screw with associated bone formation off the adjacent inferior glenoid.Stress shielding is noted in the proximal humerus and there is bone loss in the proximal humeral metaphysis.Of note, the baseplate is positioned on the cranial half of the glenoid.An os acromiale and moderate acromioclavicular joint osteoarthritis incidentally noted.It was noted that the baseplate was positioned on the cranial half of the glenoid; there is no information on initial surgery.A definitive root cause cannot be determined.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 by the patient-matched implant (pmi) group that a patient underwent a shoulder arthroplasty procedure on an unknown date.Subsequently, the patient is being considered for a pmi product on an unknown day due to pain.It appears from imaging that the patient has moderate scapular notching.The patient has not been scheduled for a revision, and due to her past medical history may not get cleared for another procedure.Attempts have been made, and no further information has been provided.

• Brand Name: 15MM POST LENGTH BASE PLATE
• 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: 25678909
• Report Number: 0001822565-2026-02401
• Device Sequence Number: 13189231
• Product Code: PHX
• UDI-Device Identifier: 00889024268999
• UDI-Public: (01)00889024268999(17)260131(10)63869345
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00434901500
• Device Lot Number: 63869345
• 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: 06/03/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Female