MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REV 36MM POLY LINER PLUS 0MM OFS; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	00434903600
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 115313, comp rvsr shldr glnsp +3 36mm, lot#: j7878159.G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.The investigation is in process.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 one (1) month ago.Subsequently, the patient the patient underwent a revision surgery seven (7) days after their initial surgery due to dislocation of the implants.Attempts have been made to obtain additional information.No additional information has been received at this time.
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, g3, g6, h2, h3, h6, h11.Corrected data: h4 device manufacturer date.No product was returned, and no pictures were provided; therefore, a product evaluation could not be performed.A review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility, with no issues noted.A review of the complaint history identified additional similar complaints for the reported item(s), but no additional complaints for the reported part and lot combination(s).Complaints are monitored through a monthly complaint review in order to identify potential adverse trends.A definitive root cause could not be determined.If any further information is found that 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
There is no update to the prior event description provided.

• Brand Name: TM REV 36MM POLY LINER PLUS 0MM OFS
• 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: 22286647
• Report Number: 0001822565-2025-02012
• Device Sequence Number: 8819902
• Product Code: PHX
• UDI-Device Identifier: 00889024633056
• UDI-Public: (01)00889024633056(17)291112(10)66915764
• 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): 10/08/2025

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: 00434903600
• Device Lot Number: 66915764
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Unknown