MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALLIANCE GLENOID GLENOID; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED

Catalog Number	SAGL2043
Medical Device Problem Codes	Positioning Failure (1158); Naturally Worn (2988)
Health Effect - Clinical Codes	Erosion (1750); Metal Related Pathology (4530)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial implantation approximately four (4) years and six (6) months ago.Subsequently, it was noted post-operatively that the tm modular peg of the glenoid penetrated the poly liner and protruded.The patient underwent a revision approximately four (4) years and five (5) months post-implantation where the initial plan was to convert from a tsa to rtsa; however, due to metallosis and severe bone resorption, implanting a glenoid implant was unable to occur.Therefore, bone was harvested from the ilium and used for a bone graft at the site of the resorption.It is noted the patient was very active, in which this event has caused post-op management difficult.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10: item# sagp0002; lot# 64783943 , item# 118001; lot# j7061058 , item# 113134; lot# 524680.G2: foreign - event occurred in japan.Customer has 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.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ALLIANCE GLENOID GLENOID
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED
• 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: 25201269
• Report Number: 0001822565-2026-01607
• Device Sequence Number: 21036790
• Product Code: KWS
• UDI-Device Identifier: 00889024574373
• UDI-Public: (01)00889024574373(17)280725(10)64813358
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• 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): 05/18/2026

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: SAGL2043
• Device Lot Number: 64813358
• 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: 04/24/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male