MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL TRAY NEUTRAL +0MM STD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	SAHTST00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); Arthropathy (4894)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had an initial shoulder arthroplasty.Subsequently, the patient underwent a revision approximately 15 days post-implantation due to unknown reasons.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).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): 110031424(6648146).Associated product information, part (lot): 115313(j7712782), 010000589(66378428), 115396(66378428), sahs1115(65498093), 180550(66625914), 180552(66554469), 180551(66637970), 180552(66602929), 115313(j7712782).The customer has not indicated whether the product will be zimmer biomet for investigation, and the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 a patient had an initial shoulder arthroplasty.Subsequently, the patient underwent a revision approximately 15 days post-implantation due to a rotator cuff tear.The patient was converted form an anatomical to a reverse shoulder system.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10 the reported event cannot be confirmed.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.Medical records were not provided.No problem found as the reported revision is related to a rotator cuff tear which is due to progression of disease overtime and not device related.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: HUMERAL TRAY NEUTRAL +0MM STD
• 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: 22874509
• Report Number: 0001822565-2025-03047
• Device Sequence Number: 17593304
• Product Code: MBF
• UDI-Device Identifier: 00889024627437
• UDI-Public: (01)00889024627437(17)340216(10)66583110
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K213856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: SAHTST00
• Device Lot Number: 66583110
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male