FDA Adverse Event
Injury
Summary report: N
DEPUY
MDR report key: 2071882
·
Received April 23, 2011
Report
- Report Number
- MW5020393
- Event Type
- Injury
- Date Received
- April 23, 2011
- Date of Event
- August 5, 2008
- Report Date
- April 23, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KXA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON (B)(6) 2008, I HAD A HIP REPLACEMENT USING THE DEPUY PINNACLE HARDWARE. ON (B)(6) 2008, THE HIP BECAME DISLOCATED AND REQUIRED A VISIT TO THE ER ON (B)(6) 2008 TO RE-SET THE HIP. THE HIP SUBSEQUENTLY BECAME DISLOCATED THREE (3) MORE TIMES BEFORE A REVISION SURGERY COULD BE PERFORMED ON (B)(6) 2008. ON (B)(6) 2008 THERE WAS A REVISION SURGERY USING THE DEPUY PINNACLE HARDWARE WITH A LINING THAT SECURES THE HIP SO THAT IT COULD NOT BECOME DISLOCATED ANY MORE. THESE DISLOCATIONS CAUSED EXCRUCIATING PAIN EACH TIME AND MY HIP NOW OFTEN ACHES AND I ALWAYS FAVOR IT FEARING THAT IT WILL BECOME DISLOCATED AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY | PINNACLE FEMORAL HEAD | KXA | DEPUY ORTHOPAEDICS, INC. | 2703214 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Hospitalization| S |