MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SIZE 3 4-PEG MODULAR CEMENTED GLENOID; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	SAGL2043
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item # 110031402, mini standard thickness +3mm taper offset 40mm diameter humeral tray, lot # 64879861.Item # 115310, comp rvrs shldr glnsp std 36mm, lot # j7974195.Item # 180550, comp lk scr 3.5hex 4.75x15 st, lot # 67420243.Item # 405889, comp rvs 2.7mm dia drl, lot # 67550677.Item # 110032430, comp aug mini bsplt w tpr lg, lot # 67221438.Item # 180551, comp lk scr 3.5hex 4.75x20 stl, lot # 67420838.Item # 180552, comp lk scr 3.5hex 4.75x25 st, lot # 67421553.Item # 110031424, cr vivacit-e 36mm brng std, lot # 67016702.Item # 00888700200, bactisure wound lavage ww, lot # q2406837.Item # 115396, comp rvs cntrl 6.5x30mm st/rst, lot # unknown.Item # 113044, versa-dial 46x21x50 hum head, lot # 528680.Item # sagp0002, modular post tm, lot # 64718354.Item # 118001, versa-dial/comp ti std taper, lot # 698760.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 patient underwent revision post implantation due to the glenoid polyethylene component was worn, resulting in the cobalt-chromium head rubbing on a metal post.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were corrected: b2.The following sections were updated: b4, b5, d6a, g3, g6, h2, h6, h11.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 5.5 years post implantation due a worn out poly glenoid component.Prior to the revision, a scope was performed which displayed metallosis due to metal-on-metal contact.Attempts have been made and no further event information is available at the time of this report.
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, g3, g6, h2, h3, h6, h11 visual examination of the provided pictures identified the poly, humeral head, and taper adaptor have been explanted and are covered in debris.The poly exhibits abnormal wear and is worn through to the glenoid base insert (metal) subcomponent, which has fractured as a result.Scratching and scuff marks are seen on the humeral head from articulation on the base insert subcomponent.Additionally, an image of the joint is shown intraoperatively, and the surrounding tissue is blackened.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history identified additional similar complaints for the reported item and part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total shoulder arthroplasty exhibits polyethylene bearing wear or compromise, metal-on-metal contact of humeral head with glenoid peg, flattening of head of the metal peg, metal debris (metallosis), mechanical erosion of posterior glenoid, and osteolysis.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.

• Brand Name: SIZE 3 4-PEG MODULAR CEMENTED GLENOID
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 24022594
• Report Number: 0001822565-2026-00125
• Device Sequence Number: 21480457
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K191814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2026

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: SAGL2043
• Device Lot Number: 64723565
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 06/09/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/11/2026; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2020
• 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; Other; Hospitalization
• Patient Sex: Female