MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Unstable (1667)

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  

Manufacturer Narrative

(b)(4).D10: 11-165232 ¿ ringloc bi-polar ¿ 580550.802202802 ¿ cocr head ¿ 65396111.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01169-1.

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 further event information available at the time of this report.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: subsequent to this, revision was performed.There is a dislocation of the right hip arthroplasty.Extensive radiolucency along the proximal femoral stem is present as noted.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: - mechanical (g04)- stem.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17123775
• MDR Text Key: 317125639
• Report Number: 0001822565-2023-01553
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024131927
• UDI-Public: (01)00889024131927(17)310530(10)64918519
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200823
• 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
• Report Date: 08/17/2023

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: 00771101500
• Device Lot Number: 64918519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 08/14/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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