FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 2192633
·
Received August 5, 2011
Report
- Report Number
- 3005477969-2011-00171
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- May 11, 2011
- Report Date
- October 3, 2011
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND LIMITED RANGE OF MOTION (ROM). A SOFT TISSUE REACTION WAS NOTED DURING REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. | 50620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R | FEMORAL HEAD: PART#74121346, LOT# 50643 |