MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X20MM ST/RST; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	115394
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): d10: item # 110032420, comp aug mini bsplt w tpr md, lot # 67016829.Item # 180552, comp lk scr 3.5hex 4.75x25 st, lot # 67299910.Item # 180552, comp lk scr 3.5hex 4.75x25 st, lot # 67286539.Item # 115313, comp rvsr shldr glnsp +3 36mm, lot # j7912269.Item # 113632, comp primary stem 12mm mini, lot # 65559371.Item # 110031403, mini tray +5mm cocr +3 offset, lot # 66058388.Item # 110031425, cr vivacit-e 36mm brng +3, lot # 66874216.Item # 405889, comp rvs 2.7mm dia drl, lot # 67133741.Item # 405800, comp.Rev shldr 9 in steinmann, lot # 66875013.Item # 406669, stn pn thd tip.125x2.5in 2pk, lot # 65922885.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.
Event or Problem Description
It was reported that a patient underwent a primary reverse shoulder procedure.Subsequently, approximately 5 months and 19 days post implantation the patient was presenting with a painful shoulder and an x-ray and ct scan showed glenoid component migration.It was noted that the patient had prior neurologic pathology and poor bone quality.The patient plans to be revised where the glenoid components will be removed while discussing further options.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information 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: b4, b7, d2a, d9, g3, g6, h2, h3, h6, h10, h11 the reported event was confirmed by review of x-rays.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the glenoid component appears loose.Generalized reduced bone mineral density may be a contributing factor to glenoid baseplate component loosening.No arthroplasty component fractures are identified.The device history record was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: COMP RVS CNTRL 6.5X20MM ST/RST
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 23843692
• Report Number: 0001825034-2025-04075
• Device Sequence Number: 15906949
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: Lay User/Patient
• Device Catalogue Number: 115394
• Device Lot Number: 67015756
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown