MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-17 for HOWMEDICA ACETABULAR SYSTEM VERTALOC SOLID BACK SHELL 6302-2-058 manufactured by Pfizer/howmedica.
[18933546]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039205 |
| MDR Report Key | 4270856 |
| Date Received | 2014-11-17 |
| Date of Event | 2002-09-23 |
| Date Added to Maude | 2014-11-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOWMEDICA ACETABULAR SYSTEM VERTALOC SOLID BACK SHELL |
| Generic Name | SHELL |
| Product Code | KWB |
| Date Received | 2014-11-17 |
| Catalog Number | 6302-2-058 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PFIZER/HOWMEDICA |
| Brand Name | SYSTEM 12 DEGREE ACETABULAR INSERT |
| Generic Name | ACETABULAR INSERT |
| Product Code | KWB |
| Date Received | 2014-11-17 |
| Catalog Number | 6302-5-075 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | PFIZER/HOWMEDICA |
| Brand Name | MERIDIAN STEM POROUS COATED STRAIGHT |
| Generic Name | STEM |
| Product Code | LPH |
| Date Received | 2014-11-17 |
| Catalog Number | 6265-0-007 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | PFIZER/HOWMEDICA |
| Brand Name | FEMORAL HEAD |
| Generic Name | FEMORAL HEAD |
| Product Code | KWY |
| Date Received | 2014-11-17 |
| Catalog Number | 6264-5-428 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | PFIZER/HOWMEDICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2014-11-17 |