MAUDE Adverse Event Report: PFIZER/HOWMEDICA FEMORAL HEAD

Catalog Number 6264-5-428

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Disability (2371)

Event Date 09/23/2002

Event Type  Injury  

Event Description

I was sitting on the couch and it just popped out and dislocated.It almost dislocated three times before, but it did not come all the way out.The first time, i was trying on new shoes, it made a pop noise, which was very scary, with some pain.The second time, i was sitting and it did it again with pop or chunk feeling in my hip.The third time, i was also sitting, and it did the same thing.All of these happened between (b)(6) 2001.To the date of the first dislocation, my hip never felt right.I told the doctor and the physical therapist after the first dislocation, it seemed to dislocate regularly.It might take one month or four or five month for it to happen.Later on, it seemed to come out all the time.The doctor that put it in died six weeks after my surgery.The doctor at the hospital told me i needed to have reconstructive surgery, which i could not afford, no insurance.The only reason i am reporting this now is because a lawyer gave me your address or web-site.I have been calling lawyers every time i saw an add on tv about bad prosthesis, about eight years.They always told me, they weren't going back that far.If it was 2002 they were going to 2001.I am supposed to have surgery on my hip right now if we can find a doctor that accepts (b)(6) for payment.Still waiting.I am wheelchair bound, now and life is extremely difficult now.

• Brand Name: FEMORAL HEAD
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): PFIZER/HOWMEDICA
• MDR Report Key: 4270856
• MDR Text Key: 18933546
• Report Number: MW5039205
• Device Sequence Number: 4
• Product Code: KWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 6264-5-428
• Patient Sequence Number: 1
• Treatment: PROCARDIA 30 MG; ADVIL; HYDROOXYZINE PAMOATE 50 MG; HYDROCODONE-ACETAMINOPHEN 12-325MG; VENLAFAXINE 75 MG; STOOL SOFTENER; PROCARDIA 60 MG; TOPROL XL TAB 50 MG; VITAMIN; METAMUCIL
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 70