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

Model Number N/A

Device Problems Unstable (1667); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)

Event Date 02/03/2023

Event Type  Injury  

Event Description

It was reported that patient fell and experienced a dislocation after a bipolar hip procedure.The surgeon tried to reduce but was unable to.It was then found that the head had separated form the liner and bipolar.The patient underwent a revision surgery approximately a week later.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).D10: 00771101620 ¿ extended offset stem ¿ 63299354.802202803 ¿ femoral head ¿ 65633002.Product will not be returning to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient experienced a fall and dislocation approximately 1-2 weeks after initial hip procedure.The surgeon attempted to reduce the dislocation and noticed that the head had disassociated from the liner and bipolar shell.The patient ultimately underwent a revision surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.00771101500 ¿ stem ¿ 64918519.802202802 ¿ cocr head ¿ 65396111.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 Description

It was reported that patient experienced a fall and dislocation approximately 3 weeks after a left hemiarthroplasty.A closed reduction was performed, but the patient dislocated again upon attempting to ambulate, closed reduction was performed again and patient was admitted to the hospital.A new greater trochanter fracture was found and determined no surgery to be performed and the patient was discharged to home.Approximately 1 week later, the patient experienced another fall and dislocation with admittance to the hospital.A closed reduction under anesthesia was attempted but unsuccessful.The surgeon noted disassociation of the products along with unstable hip fracture.The next day, the patient underwent a revision surgery of all products.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the liner was returned installed inside of the shell.There are scratches and indentations on the liner.The shell and liner could not be separated for further evaluation.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left hemiarthroplasty was performed due to a fall and femoral neck fracture.The patient reported falling at home and dislocating.There was a closed reduction, but the patient dislocated again and many times after.A new fracture on the femur was also found.Later testing showed disassociation of the bipolar components.During the revision, it was confirmed the bipolar disassociated from the head.All components were revised and replaced.The complaint is confirmed based on the provided 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.

• Brand Name: RINGLOC BI-POLAR 28X54MM
• Type of Device: 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: 16854717
• MDR Text Key: 314398554
• Report Number: 0001825034-2023-00925
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304001800
• UDI-Public: (01)00880304001800(17)251210(10)580550
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/14/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-165232
• Device Lot Number: 580550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 05/01/2023; 05/25/2023; 09/13/2023
• Supplement Dates FDA Received: 05/25/2023; 06/14/2023; 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White