MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER 4 PEG MOD GLEN SZ 4; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES

Catalog Number	SAGL2044
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 medical products: item#: sagp0001, modular post pps; lot#: 66422729.Visual examination of the returned products identified the device had signs of use and damage.No fracture is identified.Dimensional analysis could not be performed due to the damage.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: glenoid pin in place without radiolucent glenoid component seen.Possible malposition of the glenoid pin.Angulation of both of the humeral head and glenoid pin do not appear to be appropriate.Although malposition is noted in the radiographs it as no immediate post operative radiographs were provided from the initial procedure, it cannot be confirmed if this occurred as a result of the disassociation.As such, 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
It was reported that a patient had initial surgery approximately a year and a half ago.Subsequently, about 3 months later the patient had a revision due to implant fracture.When the items were pulled out the post remained in the patient and it seemed that the threaded portion of the post fractured.All pieces were removed from the patient.

• Brand Name: ZIMMER 4 PEG MOD GLEN SZ 4
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES
• 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: 22053743
• Report Number: 0001822565-2025-01479
• Device Sequence Number: 20804328
• Product Code: KWS
• UDI-Device Identifier: 00889024644786
• UDI-Public: (01)00889024644786(17)281021(10)66282126
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

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 Catalogue Number: SAGL2044
• Device Lot Number: 66282126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• 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: 04/21/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male