FDA Adverse Event
Injury
Summary report: N
SMITH & NEPHEW
MDR report key: 2153246
·
Received July 1, 2011
Report
- Report Number
- MW5021238
- Event Type
- Injury
- Date Received
- July 1, 2011
- Date of Event
- January 8, 2009
- Report Date
- June 29, 2011
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IN (B)(6) 2010, CLICKING, PAIN IN LATERAL ASPECT LEFT HIP, PAIN AT NIGHT, NO ASSISTIVE DEVICE, TROCHANTERIC BURSAL INJECTION. ON (B)(6) 2011 - PAIN CONTINUED, FOLLOW UP OFFICE VISIT, CONSERVATIVE TREATMENT FOR TROCHANTERIC BURSITIS. X-RAYS NORMAL. ON (B)(6) 2011 - SEEN IN OFFICE; RECOMMEND MRI, BLOOD WORK, PERSISTENT LEFT HIP PAIN, CLICKING, REPORTED SENSE OF GRINDING; RECOMMEND SECOND OPINION. SAME PT AS (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMITH & NEPHEW | BIRMINGHAM HIP RESURFACING IMPLANTS | JDI | SMITH & NEPHEW, INC. | 74120148 | 086655 | |
| 2 | ACETABULAR CUP FEMORAL HEAD | BIRMINGHAM HIP RESURFACING IMPLANTS | KWB | SMITH & NEPHEW, INC. | 74121142 | 077657 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |