MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR HIP SYSTEM 28X47MM; PROSTHESIS, HIP

Catalog Number	11-165218
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: unk head.G2: foreign: taiwan.The customer has indicated that the product is in process of being 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 when the nurse attempted to twist and push the liner into the cup, they would not mate.It was found that the locking ring was not in the correct position.There was no known impact or consequences to the patient.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d5; d9; g3; h2; h3; h4; h6.Visual examination of the returned product identified the shell was returned with the lock ring still retained within the lock ring groove.The lock ring is confirmed to have a correct chamfer orientation.The lock ring is bent/twisted with multiple grooves present on the bottom side.The poly insert has gouges/indentations around the outer diameter and inner diameter.Surfaces with multiple of the 12 slits being enlarged.There are also grooves running around the outer diameter of the insert.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot 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 further information at the time of this report.

• Brand Name: RINGLOC BI-POLAR HIP SYSTEM 28X47MM
• 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: 22123879
• Report Number: 0001825034-2025-01536
• Device Sequence Number: 7273969
• Product Code: JDI
• UDI-Device Identifier: 00880304209688
• UDI-Public: (01)00880304209688(17)290727(10)66663131
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: 11-165218
• Device Lot Number: 66663131
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2024
• 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
• Patient Sex: Female