MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X44MM; PROSTHESIS, HIP

Catalog Number	11-165212
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shell did not assemble properly and a part of it was broken.There was no harm or health impact to the patient.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.D10: cat #: 11-165302, lot #: 715800, rnglc biplr replc ring.Visual examination of the returned product identified the bipolar was assembled upon return with no visible defects.The second locking ring was bent in multiple places and has scuffing on the surface.Due to the damage to the locking ring no measurements were taken.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Review of the available information indicates the device was assembled per technique, was released in a conforming state, and is functioning as expected per the documented design requirements.No device failure was identified.Could not confirm assembly and mobility issue for head and liner.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 28X44MM
• 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: 20395305
• Report Number: 0001825034-2024-02357
• Device Sequence Number: 6465149
• Product Code: JDI
• UDI-Device Identifier: 00880304209640
• UDI-Public: (01)00880304209640(17)270510(10)259650
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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: 11-165212
• Device Lot Number: 259650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2024
• 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: 09/14/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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
• Patient Sex: Female