MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE 36MM GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	00434903611
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial an initial left shoulder arthroplasty approximately, six (6) years and nine (9) months ago.Subsequently, the patient underwent a revision surgery due to pain and dislocation of the implants.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 00435003600, 36mm vit e liner +0mm; lot#: 64054234.Item#: 00434901500, 15mm post length base plate; lot#: 63799890.Item#: 01.04223.036, invers/revers scr syst 4.5-36; lot#: 63799890.Item#: 01.04223.036, invers/revers scr syst 4.5-36; lot#: 2937875.G2: foreign: japan.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.H6: component codes: mechanical (g04)- head.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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; h3; h6.The following section was corrected: d5.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.With the provided information on the timing of the event, it cannot be determined if loosening or dislocation was the primary failure.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.

• Brand Name: TM REVERSE 36MM GLENOSPHERE
• 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: 22046826
• Report Number: 0001822565-2025-01450
• Device Sequence Number: 15673514
• Product Code: PHX
• UDI-Device Identifier: 00889024269088
• UDI-Public: (01)00889024269088(17)271031(10)63800883
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/16/2025

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: 00434903611
• Device Lot Number: 63800883
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2017
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown