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

Catalog Number	11-165206
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 approximately six weeks post-implantation, the patient underwent a hip revision due to dislocation.The patient fell and dislocated their hip.The surgeon attempted closed reduction and then the cup and head separated so the patient was revised.It was reported no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; d9; g3; h2; h3; h4; h6; h10.Visual examination of the returned product identified the device was returned with the poly insert assembled within the shell/lock ring assembly.Due to the assembled state of the device, there are no visible product markings to verify.There are minor scratches to the top flat surface of the shell and poly insert.The poly insert has minor scratches present in the i.D.As well.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing for the ringloc.Medical records were not provided.A definitive root cause cannot be determined.It was reported the patient fell; however, the cause of the fall is unknown.Per the ifu ¿acetabular prosthesis can dislocate.Closed reduction is generally successful; however closed reduction must be attempted with caution to prevent disassociation of the bi-polar acetabular component from the femoral component.When dislocated, the bi-polar component can assume a vertical position and become impinged against the natural acetabulum.When impinged, during closed reduction, the bi-polar component can experience forces greater than the lever out forces or torque forces required to disassociate (separate) the bi-polar component from the femoral component.¿.Complaint is not 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.
Event or Problem Description
No further information is available at the time of this report.

• 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: 23592975
• Report Number: 0001825034-2025-03691
• Device Sequence Number: 13294193
• Product Code: JDI
• UDI-Device Identifier: 00880304001923
• UDI-Public: (01)00880304001923(17)300116(10)67026992
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K051569
• 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): 04/29/2026

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: 11-165206
• Device Lot Number: 67026992
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown