MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR; PROSTHESIS, HIP

Catalog Number	11-165226
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in canada.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that during hip surgery the liner with the head could not be inserted in the cup.Another device was used to complete the procedure.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d9; g3; h2; h3; h6.Visual examination of the returned product identified the poly insert assembled within the shell/lock ring, the poly insert is able to rotate.Due to the assembled state of the device there is no visible etch to confirm.There are scratches around the top flat surface and top outside chamfer of the poly insert.The top edge on multiple of the removal slots for the poly insert have burr like material and visually appear deformed.No other damage was noted during visual evaluation.Measurements within specification.It is unknown if the burr like material was caused during the assembly of the liner and shell.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.Complaint is confirmed.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.

• Brand Name: RINGLOC BI-POLAR
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23797875
• Report Number: 0001825034-2025-03971
• Device Sequence Number: 10452935
• Product Code: JDI
• UDI-Device Identifier: 00880304209732
• UDI-Public: (01)00880304209732(17)300812(10)67389096
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 11-165226
• Device Lot Number: 67389096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 12/13/2025
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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
• Patient Sex: Unknown