FDA Adverse Event
Injury
Summary report: N
JOHNSON & JOHNSON
MDR report key: 2861419
·
Received December 3, 2012
Report
- Report Number
- MW5027959
- Event Type
- Injury
- Date Received
- December 3, 2012
- Date of Event
- October 11, 2010
- Report Date
- November 7, 2012
- Manufacturer
- DEPUY INC., A JOHNSON & JOHNSON
- Product Code
- KWY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
MY EXPLANT COMPONENTS DO NOT MATCH MY HOSPITAL CHART STICKER INFO. THE (FEMORAL BALL HEAD) INFO ON EXPLANT: 32MM C 5MM EXT JJO (B)(4) DOES NOT MATCH SURGERY RECORDS FROM 1996 OR 2005. HAVE HAD 3 HIP REPLACEMENTS: (B)(6) 1996, (B)(6) 2005, AND (B)(6) 2010; ALL WHICH WERE DONE BY DR (B)(6). MY SECOND HIP (B)(6) 2005, FAILED PREMATURELY AND NEVER FELT RIGHT COMPARED TO THE 1ST AND 3RD. DR DISMISSED ME AS PT ARBITRARILY AND REFUSES TO PROVIDE ME OR MY NEW DOCTOR MY COMPLETE MEDICAL RECORDS NOR WILL HE EXPLAIN WHY THIS HAPPENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JOHNSON & JOHNSON | HIP HEAD | KWY | DEPUY INC., A JOHNSON & JOHNSON | 55759 | ||
| 2 | DEPUY P.F.C. | FEMORAL BALL HEAD / HIP HEAD | KXA | DEPUY ORTHOPAEDICS INC | 1935139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization| R| S |