FDA Adverse Event
Other
Summary report: N
CLP HIP
MDR report key: 2467761
·
Received February 15, 2012
Report
- Report Number
- 1644408-2012-00072
- Event Type
- Other
- Date Received
- February 15, 2012
- Date of Event
- January 29, 2012
- Report Date
- January 29, 2012
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWJ
- PMA / PMN Number
- K910010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE PT FELL AND BROKE THEIR FEMUR. THE PRODUCT DID NOT FAIL, HOWEVER, IT DID NEED TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLP HIP | STANDARD OFFSET STEM | KWJ | ENCORE MEDICAL, L.P. | 142C1009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Required Intervention | (B)(4), LOT 631C1057| (B)(4), LOT 991B1040 |