MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X30MM ST/RST; PROSTHESIS, SHOULDER

Catalog Number	115396
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2 : foreign : australia.Customer has not indicated that if that product will be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that there was a revision due to implant breakage.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that there was a revision due to implant breakage.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: a1; a2; d1; d4; d6; g4; h3; h4; h6.Follow-up report with updated information.Investigation is still in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b7; h2; h3; h6; h11.The reported event could not be confirmed due to lack of product/information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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
It was reported that the patient underwent a revision approximately 11.5 months post-implantation due to a broken central screw.The glenoid was revised to a comprehensive glenoid component.Attempts have been made and no further information has been provided.

• Brand Name: COMP RVS CNTRL 6.5X30MM ST/RST
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 23208254
• Report Number: 0001822565-2025-03639
• Device Sequence Number: 10061758
• Product Code: PHX
• UDI-Device Identifier: 00880304677081
• UDI-Public: (01)00880304677081(17)340503(10)66713509
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132239
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2026

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: 115396
• Device Lot Number: 66713509
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 10/02/2024; 01/09/2026
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 10/31/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown