MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER LARGE AUGMENTED BASEPLATE WITH MINI TAPER ADAPTER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110032430
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: associated medical products, part (lot): 113630 (64909774).115394 (383530r).180550 (918160).180551 (372630).180551 (372630).405800 (246800).405800 (246900).110030777 (65398250).110031399 (65411984).110031427 (65838110).20-8090-004-01 (66002321).G2: foreign - the event occurred in australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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 experienced baseplate loosening from the glenoid following an initial arthroscopy procedure.The patient's anatomy, with very little bone in the glenoid, was indicated by the surgeon to have caused the failure.Imaging confirmed this loosening approximately fifteen (15) months later.A future revision is planned on an unknown date.No other interventions or harms have been reported due to this event.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Corrections to d10 concomitant devices.D10: concomitant medical products, part (lot): 115394 (383530r), 180550 (918160), 180551 (372630), 180551 (372630).Associated medical products, part (lot): 113630 (64909774), 405800 (246800), 405800 (246900), 110030777 (65398250), 110031399 (65411984), 110031427 (65838110), 20-8090-004-01 (66002321).If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.The reported loosening and screw fracture events are confirmed by the provided x-rays.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a healthcare professional.A review of the available records identified the following: initial anatomic alignment of the reverse-type left shoulder arthroplasty with subsequent loosening and superior migration of the glenoid implant and a fractured screw.Bone quality is osteopenic.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 report 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.
Event or Problem Description
It was reported that a patient experienced baseplate loosening from the glenoid following an initial arthroscopy procedure.The surgeon indicated the patient's anatomy, with very little bone in the glenoid, likely caused the failure.Imaging confirmed this loosening approximately fifteen (15) months later.Additionally, one (1) of the peripheral screws was found to be fractured during radiograph evaluation.A future revision is planned on an unknown date.No other interventions or harms have been reported due to this event.Attempts have been made, and no further information has been provided.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER LARGE AUGMENTED BASEPLATE WITH MINI TAPER ADAPTER
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 19582106
• Report Number: 0001825034-2024-01662
• Device Sequence Number: 17973443
• Product Code: PHX
• UDI-Device Identifier: 00880304993259
• UDI-Public: (01)00880304993259(17)270425(10)65255617
• 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: 2023
• 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,Followup
• Report Date (Section B): 10/08/2024

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: 110032430
• Device Lot Number: 65255617
• 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: 05/27/2024
• Supplement Date Received by Manufacturer: 09/03/2024; 10/03/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 09/27/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• 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: H11.; H11.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male