MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIGLIANI/FLATOW SHOULDER OFFSET MODULAR HUMERAL HEAD 21 MM HEIGHT 52 MM DIAM; 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 Codes	Joint Laxity (4526); Arthropathy (4894)
Date of Event	10/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: austrailia.H6: proposed code: mechanical (g04) stem.Customer has not indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent a shoulder replacement on an unknown date.Subsequently, the patient was revised due to instability.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported the patient underwent a right anatomic shoulder replacement approximately 9 years ago.Subsequently, the patient was revised due to instability.It was additionally reported that the patient was exchanged to a reverse due to rotator cuff failure.Removed tm stem and bigliani humeral head.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 updated/corrected.Updated: a1; a2; a3; b5; d11; d2; d4; d6; d10; e1; g4; h2; h3; h4; h6; d10: 00430008700 lot 62784745 glenoid component pegged 52 mm diameter articular surface used with blue (52 mm) instruments.00434811413 lot 63069544 humeral stem 48 degrees 14 mm stem diameter 130 mm stem length.This report is to update the event as op records were received and part number was updated; an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h2; h4; h6; h11.The reported event could not be confirmed due to lack of product/information.Review of the reported event by a health care professional found: the rotator cuff is a group of muscles and tendons that surround the shoulder joint, keeping the head of the humerus firmly within the shallow socket of the shoulder.Rotator cuff injuries occur most often in people who repeatedly perform overhead motions or experience any sort of trauma to the shoulder.Degenerative tears can also occur because of the gradual wearing down of the tendon.This degeneration naturally occurs as we age.Factors that lead to degenerative tears include repetitive stress, lack of blood supply, bone spurs, and increased age.Common symptoms of a rotator cuff tear include pain at rest or with activity, weakness, and crepitus.Typically, an anatomic shoulder is performed when the rotator cuff is stable and intact, and a reverse shoulder is performed for an insufficient rotator cuff.Product has not been evaluated as it has been determined the event is not related to device.The device history record was not reviewed; a review of the device history record and complaint history review will not be completed for limited investigation complaints as the product meets the applicable acceptance criteria.Root cause has been identified as unrelated to the device.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
No further event information available at the time of this report.

• Brand Name: BIGLIANI/FLATOW SHOULDER OFFSET MODULAR HUMERAL HEAD 21 MM HEIGHT 52 MM DIAM
• 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: 23511684
• Report Number: 0001822565-2025-04047
• Device Sequence Number: 21258959
• Product Code: KWT
• UDI-Device Identifier: 00889024265783
• UDI-Public: (01)00889024265783(17)250831(10)63126195
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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,Followup
• Report Date (Section B): 02/20/2026

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: 08/31/2025
• Device Catalogue Number: 00430205221
• Device Lot Number: 63126195
• 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: 10/11/2025
• Supplement Date Received by Manufacturer: 01/22/2026; 02/20/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 02/19/2026; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2015
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male