FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 3082077
·
Received April 29, 2013
Report
- Report Number
- 3005477969-2013-00160
- Event Type
- Injury
- Date Received
- April 29, 2013
- Date of Event
- April 23, 2012
- Report Date
- January 29, 2014
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS LTD
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN. MRI FINDINGS REPORTEDLY INDICATED AN ADVERSE REACTION TO METAL DEBRIS. ELEVATED METAL ION LEVELS REPORTED.
Description of Event or Problem · 1
(B)(6) 2007 AND (B)(6) 2008 THE PATIENT REPORTED A CLUNKING SENSATION. (B)(6) 2008 RESIDUAL PAIN AND NOISE WHEN SITTING REPORTED. (B)(6) 2009 INTERMITTENT PAIN REPORTED. (B)(6) 2011 INCREASED PAIN, FLUID AND INFLAMMATION AROUND JOINTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185831 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Hospitalization| R | MODULAR SLEEVE, PART # 74222100, LOT # UNKNOWN| FEMORAL STEM, PART # 71309012, LOT # UNKNOWN| MODULAR HEAD, PART # 74222150, LOT # UNKNOWN |