MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER SYSTEM PROLONG POLYETHYLENE BEARING; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110031421
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item# sahtnem6; lot# 67066430.Item# 110030776; lot# 66735695.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 a reverse shoulder arthroplasty on approximately four (4) months ago.Subsequently, the patient reported instability a couple of months post-implantation.Patient underwent a revision approximately three (3) months post-implantation, where it was discovered that the poly liner had disassociated from the humeral tray.The glenosphere, tray and poly were all exchanged during the revision.It was noted that the patient was not compliant with post-op instructions by not wearing their sling nor adhering to the rom guidelines suggested by the surgeon.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.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h4; h6; h10 visual examination of the returned product/provided pictures identified the bearing returned shows signs of wear and tear.There are gouges on the bottom side of the bearing and around the outside edge of the bearing.Measured the bearing and it is conforming to the print specification.The tray also shows signs of use and wear and tear.There are scuff marks on the top and bottom sides of the tray.There is wear and tear on the surface where the poly bearing would sit.Measured the product identifiers of the tray and the tray is conforming to the print specification.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.It was noted that patient noncompliance could be a factor.The reported event is not confirmed.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER SYSTEM PROLONG POLYETHYLENE BEARING
• 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: 21876849
• Report Number: 0001822565-2025-01092
• Device Sequence Number: 18055775
• Product Code: PHX
• UDI-Device Identifier: 00887868231520
• UDI-Public: (01)00887868231520(17)290730(10)66817475
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: 110031421
• Device Lot Number: 66817475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2025
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Male