MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM POLY LINER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	00434903603
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had an initial left reverse total shoulder arthroplasty approximately seven (7) weeks ago.Subsequently, the patient developed symptoms of instability and could pop the shoulder joint in and out of place with little pain.The patient underwent a revision of all products except the humeral stem approximately four (4) weeks post-implantation.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# 115310; lot# j7855039.Item# 405800; lot# 67152731.Item# 00434901413; lot# 66187967.Item# 180551; lot# 67132430.Item# 180557; lot# 66554499.Item# 010000589; lot# 66546805.Item# 180550; lot# 66963133.Item# 180560; lot# 67064347.G2: foreign - event occurred in australia.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.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, h2, h6.The reported event was unable to be confirmed.Visual examination of the provided photographs identified the explanted products with bio debris and scuffs from implantation and explantation.Review of the device history records identified no deviation or anomalies during manufacturing.Medical records were provided and reviewed by a healthcare professional.Review of the available records identified the following: at the time of initial surgery, implants were very stable without impingement and no intra-op complications.Follow up imaging showed components in satisfactory position and increased lucency around the proximal humerus and the glenoid but there is no apparent acute abnormality.Approximately 3 weeks post implantation, patient had symptoms of instability; patient can comfortably pop the shoulder in and out of place with little pain.Patient was subsequently revised, for which no operative record was provided.A definitive root cause could not 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 additional information to report at this time.

• Brand Name: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM POLY LINER
• 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: 22012446
• Report Number: 0001822565-2025-01357
• Device Sequence Number: 7893350
• Product Code: PHX
• UDI-Device Identifier: 00889024633063
• UDI-Public: (01)00889024633063(17)290717(10)66744344
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 06/20/2025

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: 00434903603
• Device Lot Number: 66744344
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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 Age: 74 YR
• Patient Sex: Male