MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALLIANCE GLENOID MODULAR 3 PEG SIZE 5; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES

Catalog Number	SAGL2035
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: sagp0002, modular post tm; lot#: 65043645.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty approximately three (3) years and four (months) ago.Subsequently, the patient underwent a revision surgery due to wear of the implant.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; d2; g2; g3; g6; h1; h2; h3; h6.The following sections were corrected: b5; h6.Visual examination of the provided pictures identified the glenoid was explanted.The backside of the glenoid shows signs of implantation with biodebris, scratches, and the poly that holds the metal subcomponent in place (overmolding) has fractured off; the articulating surface shows abnormal wear and scratches.Product information cannot be verified.Review of the device history record(s) 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: left total shoulder arthroplasty with anterior and superior subluxation of the humeral component, abutment of the greater tuberosity along the under surface of the acromion and ac joint but no definite dislocation.Osteopenia noted.No radiolucency.Operative notes were not provided.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
It was reported that the patient underwent an initial shoulder arthroplasty approximately three (3) years and four (months) ago.Subsequently, the patient underwent a revision surgery due to wear of the implant.Upon removal of the implant, it was found to be fractured.

• Brand Name: ALLIANCE GLENOID MODULAR 3 PEG SIZE 5
• 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: 20410107
• Report Number: 0001822565-2024-03216
• Device Sequence Number: 18122857
• Product Code: KWS
• UDI-Device Identifier: 00889024574274
• UDI-Public: (01)00889024574274(17)290214(10)64975086
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K191814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: SAGL2035
• Device Lot Number: 64975086
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male