MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO FX HIP SYSTEM STANDARD FEMORAL STEM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Patient was revised due to a fall resulting in a bone fracture.It was reported that during pt, the patient performed a twisting motion which caused the fall and bone fracture in already poor bone quality.The standard postoperative hip precautions are not bending >90°, avoid twisting or pivoting at the hip, no crossing the legs.Bone quality (density, strength & weakness of a bone) is influenced by many internal and external factors.As people age, the rate of bone metabolism changes as bone breakdown (catabolism) occurs at a faster rate than new bone formation (anabolism), which places them at risk for osteoporosis.Risk factors that contribute to poor bone quality include; age, bmi, diet, smoking, alcohol consumption, vitamin intake, hormone imbalance, growth factors, thyroid condition, steroid use, renal function, diabetes, blood disorders, trauma, fractures, bone on bone wear, surgical trauma or invasive procedures, infections such as osteomyelitis, necrosis of the bone tissues due to disease processes, and genetic history of family members with osteoarthritis or osteoporosis.Medications taken to prevent osteoporosis further inhibit normal bone formation and healing.Bone quality concerns are patient-dependent, patient-specific, and multivariate.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
It was reported that approximately 3 weeks post-implantation, the patient underwent a hip revision due to a fall and bone fracture that occurred while being twisted in rehab.Attempts have been made and no further information has been provided.

• Brand Name: ECHO FX HIP SYSTEM STANDARD FEMORAL STEM
• 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: 19633197
• Report Number: 0001825034-2024-01706
• Device Sequence Number: 8535455
• Product Code: KWA
• UDI-Device Identifier: 00887868261114
• UDI-Public: (01)00887868261114(17)330525(10)65962456
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K063614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 12-151313
• Device Lot Number: 65962456
• 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: 02/21/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male