MAUDE Adverse Event Report: Zimmer Biomet, Inc. 4 PEG MOD GLEN SZ 2; Shoulder Prosthesis

Catalog Number	SAGL2042
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a follow-up examination, radiographs showed that the glenoid post and glenoid component had completely dissolved.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10: item # sagp0002, modular post tm, lot # 65157907 item # 113628, comp primary stem 8mm mini, lot # 65066705 item # 118001, versa-dial/comp ti std taper, lot # j7089142 item # 113034, versa-dial 42x21x43 hum head, lot # j7144793 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: 4 PEG MOD GLEN SZ 2
• Common Device Name: Shoulder Prosthesis
• 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 ; +1(574)526-0384
• MDR Report Key: 50165705
• Report Number: 0001822565-2026-02790
• Device Sequence Number: 10040650
• Product Code: KWS
• UDI-Device Identifier: 00889024574366
• UDI-Public: (01)00889024574366(17)280109(10)64859948
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K191814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: SAGL2042
• Device Lot Number: 64859948
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2020
• 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: Other
• Patient Sex: Unknown