MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI STANDARD THICKNESS +3MM TAPER OFFSET 40MM DIAMETER HUMERAL TRAY; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	110031402
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Noise, Audible (3273)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 110031424, standard 36mm diameter bearing; lot#: 66215691.G2: foreign: new zealand.H3: 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.
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty approximately nine (9) months ago.The patient on and unknown date presented with a dislocated shoulder that was reduced.Subsequently, the patient was revised approximately one (1) month ago due to instability and an audible clunk.The surgeon noted that the bearing had disassociated from the tray.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.Visual examination of the returned product/provided pictures identified the tray shows wear from use.The bottom of the tray shows some scratches and damage.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided, however as the provided radiographs were not dated evaluation could not be completed.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
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h6.The following sections were corrected: d9; h3.Visual examination of the returned product/provided pictures identified the tray shows wear from use.The bottom of the tray shows some scratches and damage.The returned humeral tray shows some wear on the inside portion of the tray where the bearing would sit, as well as scratches on the bottom of the tray.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided, however as the provided radiographs were not dated evaluation could not be completed.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.

• Brand Name: MINI STANDARD THICKNESS +3MM TAPER OFFSET 40MM DIAMETER HUMERAL TRAY
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/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: 20664433
• Report Number: 0001822565-2024-03550
• Device Sequence Number: 8237304
• Product Code: PHX
• UDI-Device Identifier: 00887868231346
• UDI-Public: (01)00887868231346(17)331124(10)66259392
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 03/06/2025

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: 110031402
• Device Lot Number: 66259392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 01/28/2025; 02/28/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 02/03/2025; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown