MAUDE Adverse Event Report: ZIMMER, INC. FEMORAL FRACTURE HARDWARE; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Device Problem Product Quality Problem (1506)

Patient Problem Pain (1994)

Event Date 07/27/2020

Event Type  Injury  

Event Description

Reporter states that her femoral fracture hardware was to big and cause severe pain until she had it removed.Reporter was told by her surgeon that this device is one size fits all.She states that she is 5ft 4in tall and how could someone her height fit the same device of someone that is six feet tall.The reporter states that she was in consistent pain with and had to use opiate drugs.She used the opioids until her prescription ran out."zimmer must be giving payments to doctors so that they will implant this device in people.I will keep talking to all media until something gets done to stop zimmer.".

• Brand Name: FEMORAL FRACTURE HARDWARE
• Type of Device: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 15130288
• MDR Text Key: 297004248
• Report Number: MW5111181
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/28/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female