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

Catalog Number	11-165208
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat: 802202802, lot: 66840290, femoral 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 approximately one month post-implantation, the patient fell and dislocated their hip.Doctor initially chose to complete a closed reduction.Then the cup and head separated and the patient underwent a revision procedure.It was reported that 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: d9; g3; h2; h3; h6.The following sections were corrected: h4.Visual examination of the returned product identified the ringloc bipolar is unable to confirm any etch identification as they are inside the shell and the liner was returned seated in the shell and was not separated during evaluation.Shell has scratches on the spherical surface.Liner has scratches to the inner spherical surface and deformation on the rim.No other damage was noted.Shell measured within specification.Liner was unable to be measured while being seated in the 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.It was reported the patient fell leading to a dislocation and subsequent closed reduction; however, it is unknown if the devices caused or contributed to the reported fall.As per ifu, the ringloc bi-polar 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.This complaint cannot be 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 HIP SYSTEM
• 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: 22043508
• Report Number: 0001825034-2025-01448
• Device Sequence Number: 8781481
• Product Code: JDI
• UDI-Device Identifier: 00880304009110
• UDI-Public: (01)00880304009110(17)290911(10)66840604
• 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): 09/22/2025

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: 11-165208
• Device Lot Number: 66840604
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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: Required Intervention; Hospitalization
• Patient Sex: Female