MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR HIP SYSTEM 28X54MM; PROSTHESIS, HIP

Model Number	N/A
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	07/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# nk 430k lot# 52889606 aesculap isodur prostethesis head.G2: foreign: russia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient dislocated approximately 1 week later.A closed reduction was performed to fix the dislocation; however, it was unsuccessful.During the closed reduction, the cup and liner disassembled.A revision occurred immediately following the closed reduction.All original devices remain implanted in 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}.
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient dislocated approximately 2 weeks later.A closed reduction was performed to fix the dislocation; however, it was unsuccessful.During the closed reduction, the cup and liner disassembled.A revision occurred immediately following the closed reduction.All original devices remain implanted in the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no related 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: displacement of the acetabular implant from the native acetabulum as noted with resulting dislocation.Medial wall acetabulum and inferior/superior pubic ramus fractures as noted, of uncertain acuity.Osteopenia.A definitive root cause cannot be determined.Per 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.Additionally, biomet has evaluated the compatibility of biomet devices with implants and components from zimmer orthopedic companies.Only authorized combinations should be used.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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 28X54MM
• 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: 20384116
• Report Number: 0001825034-2024-02345
• Device Sequence Number: 6567007
• Product Code: JDI
• UDI-Device Identifier: 00880304001800
• UDI-Public: (01)00880304001800(17)270805(10)700100
• 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
• 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,Followup
• Report Date (Section B): 11/04/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-165232
• Device Lot Number: 700100
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 11/01/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/17/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 75 KG