MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE® REVERSE SHOULDER SYSTEM MINI HUMERAL TRAY; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110031406
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part number (lot number): 110031429 (65494023).Associated product information, part number (lot number): 113629 (65576362).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was not allowed per hospital policy.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 the patient underwent an initial left total shoulder on an unknown date with unknown implants.It was reported that the patient had multiple revisions due to instability.Subsequently, approximately one (1) year and ten (10) months after the last revision, the patient was revised for a fourth time due to instability and poly disassociation.No further details provided.It was reported that no further information is available.
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.Visual examination of the provided pictures identified a humeral tray and bearing have been explanted.The humeral tray is covered in biodebris and appears to have some discoloration, although it cannot be determined if these are remnants of biodebris.The lot number is confirmed with the product etch.The bearing is also covered in biodebris and shows signs of use with deformation along the rim and locking features; the bottom/mating surface also has grooves/markings.A review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records for the previous surgery were provided and reviewed by a health care professional.A review of the available records identified the following: metallosis debrided.Implants stable.No intraoperative complications.Implanted a competitor expanded sphere with the comprehensive tray and polyethlyene liner.Revision operative notes and radiographs were not provided.Per the ifu, "only authorized combinations of humeral bearings and glenospheres should be used with the comprehensive reverse mini humeral trays.The use of instruments or implant components from other systems unless expressly labeled can result in inaccurate fit, incorrect sizing, excessive wear and device failure." as the comprehensive humeral tray and bearing were implanted with a competitor expanded sphere, which is not an approved combination, this disassociation event is attributed to off label use.The reported off label use is confirmed from provided medical records, the reported revision is confirmed from provided pictures, but the reported disassociation event is not confirmed.A summary of the investigation was sent to the complainant, conveying proper surgical technique and use of the device.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.

• Brand Name: COMPREHENSIVE® REVERSE SHOULDER SYSTEM MINI HUMERAL TRAY
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 21145334
• Report Number: 0001822565-2025-00110
• Device Sequence Number: 18553195
• Product Code: PHX
• UDI-Device Identifier: 00887868231384
• UDI-Public: (01)00887868231384(17)320306(10)65255275
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: Lay User/Patient
• Device Catalogue Number: 110031406
• Device Lot Number: 65255275
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male