MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP AUG MINI BSPLT W TPR SM; SHOULDER PROSTHESIS/EXTREMITIES

Catalog Number	110032410
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced another glenosphere disassociation approximately four years after the last revision surgery.The patient had a history of prior revision shoulder arthroplasty on an unknown date.Approximately four years after that prior revision, the glenosphere again disassociated.The patient subsequently underwent revision surgery, and the affected components were explanted approximately 3 years and 10 months post implantation.No information was provided regarding intra-operative findings or environmental factors.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: unknown, unknown taper; lot#: unknown.Item#: 115313, comp rvsr shldr glnsp +3 36mm; lot#: 518610.Item#: 00434903603, 36mm a +3mm offset poly liner; lot#: 64596739.G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, d1, d4, d10, g4, g6, h2, h3, h6, h8, h11.D10: item # 115313, comp rvsr shldr glnsp +3 36mm, lot # 518610.Item # 00434903603, 36mm ã¿ +3mm offset poly liner, lot # 64596739.Item # 00434903909, 9mm humeral stem spacer, lot # 63700523.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history identified additional similar complaints for the reported item(s) and part and lot combination(s).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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMP AUG MINI BSPLT W TPR SM
• Common Device Name: SHOULDER PROSTHESIS/EXTREMITIES
• 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: 23511452
• Report Number: 0001825034-2025-03541
• Device Sequence Number: 9705087
• Product Code: KWS
• UDI-Device Identifier: 00880304993235
• UDI-Public: (01)00880304993235(17)250921(10)64895881
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 03/24/2026

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 Expiration Date: 09/21/2025
• Device Catalogue Number: 110032410
• Device Lot Number: 64895881
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• 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 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Unknown
• Patient Weight: 78 KG