MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET MODULAR HUMERAL HEAD 21 MM HEAD HEIGHT 52 MM SPHERICAL HEAD DIAMETER; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	00430205221
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a shoulder arthroplasty.Subsequently, the patient was revised due to glenoid pain.The glenoid and humeral head were removed and replaced.There was harm/injury to the patient as the patient had to underwent additional surgical/medical intervention.Due diligence complete.Attempts were made but no additional information was provided.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).D10 narrative: item: unknown glenoid lot: unknown item name: unknown glenoid.H6 component codes: mechanical (g04) - head.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, d4, d9, g1, g3, g6, h2, h4, h11.D10 narrative: item: unknown glenoid lot: unknown item name: unknown glenoid h6 component codes: mechanical (g04) - head the product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
No additional information is available regarding the incident.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were corrected: d4: udi (this device was manufactured prior to udi mandate).The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11 visual examination of the returned products identified there are scratches and gouges to the o.D.Articulating surface of the head.There is also some foreign debris present on the o.D.Articulating surface.No other damage was noted during visual evaluation.Product identifiers where measured were conforming.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is not confirmed.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: OFFSET MODULAR HUMERAL HEAD 21 MM HEAD HEIGHT 52 MM SPHERICAL HEAD DIAMETER
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 21962456
• Report Number: 0001822565-2025-01254
• Device Sequence Number: 7228015
• Product Code: KWT
• UDI-Device Identifier: 00889024265783
• UDI-Public: (01)00889024265783(17)230831(10)62428785
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/27/2025

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 Expiration Date: 08/31/2023
• Device Catalogue Number: 00430205221
• Device Lot Number: 62428785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 08/20/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/16/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2013
• 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: Required Intervention; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Male