MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP AUG MINI BSPLT W TPR SM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110032410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Bone Notching (4890)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent revision approximately 3 years and 10 months post implantation due to patient experiencing pain from shoulder replacement.Review of ct showed notching.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: item # 115310, comp rvrs shldr glnsp std 36mm, lot # 834080, item # 110031999, tensile test specmn 2.375 1050, lot # 65118456, item # 110031424, cr vivacit-e 36mm brng std, lot # 64980771, item # 110032410, comp aug mini bsplt w tpr sm, lot # 65124582, item # 113646, comp primary stem 6mm std, lot # 279200, item # 115310, comp rvrs shldr glnsp std 36mm, lot # 834080, item # 115397, comp rvs cntrl 6.5x35mm st/rst, lot # 437730, item # 180550, comp lk scr 3.5hex 4.75x15 st, lot # 464070, item # 180551, comp lk scr 3.5hex 4.75x20 st, lot # 162940, g2: foreign - event occurred in australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.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.Review of complaint history identified additional similar complaints for the reported items and no additional complaints for the reported part and lot combinations.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: visit 1 pre-op (no date) single ap x-ray view of the right shoulder shows presence of reverse total shoulder arthroplasty components.The glenoid component is positioned high with a relatively neutral alignment.Scapular notching (mechanical erosion) is present at the inferior glenoid at the scapular pillar.Small chronic ossifications inferior to the glenohumeral joint may be related to inferior glenoid fracture fragments in the vicinity of scapular notching (versus less likely heterotopic ossifications).A definitive root cause cannot be determined.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
No further event information is available at the time of this report.

• Brand Name: COMP AUG MINI BSPLT W TPR SM
• 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: 23639436
• Report Number: 0001825034-2025-03767
• Device Sequence Number: 9203545
• Product Code: KWS
• UDI-Device Identifier: 00880304993235
• UDI-Public: (01)00880304993235(17)260727(10)65124582
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 04/09/2026

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 Expiration Date: 07/27/2026
• Device Catalogue Number: 110032410
• Device Lot Number: 65124582
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female