MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X50MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure 2 months post implantation due to due to recurrent dislocation.The surgeon initially attempted a closed reduction 14 days post op however disassembly occurred.The surgeons connected all components of the disassembled ringloc without the implantation of any new items.After the second dislocation and attempt at closed reduction again, disassembly again occurred resulting in the surgeon deciding to replace the ringloc bipolar.There is no further information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 30.28.06 item name protasul-s-30-head 28 m lot # 3174673.G2: foreign: russia.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, g3, g6, h2, h6, h11.Visual examination of the provided pictures identified the cup/ring/bearing all assembled and the head disassembled.No visible damage can be seen in the images.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: dislocation of the acetabular implant of the right hip arthroplasty.A definitive root cause cannot be determined.Under the warning section, it states 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.Also noted in the ifu it states in any instance where a liner engages the ringloc locking ring and the liner is subsequently removed or replaced, the ringloc locking ring should be replaced with a new ring, as the same components were used and a new ring wasn't placed this would be considered off label use.Event confirmed via medical records.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
There is no update to the prior event description provided.

• Brand Name: RINGLOC BI-POLAR 28X50MM
• Common Device Name: PROSTHETIC, 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: 20545362
• Report Number: 0001825034-2024-02527
• Device Sequence Number: 7481238
• Product Code: JDI
• UDI-Device Identifier: 00880304005372
• UDI-Public: (01)00880304005372(17)270611(10)444330
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K051569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/31/2024

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 Model Number: N/A
• Device Catalogue Number: 11-165224
• Device Lot Number: 444330
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male