FDA Adverse Event
Other
Summary report: N
FMP HIP
MDR report key: 3290007
·
Received August 9, 2013
Report
- Report Number
- 1644408-2013-00422
- Event Type
- Other
- Date Received
- August 9, 2013
- Date of Event
- July 29, 2013
- Report Date
- July 26, 2013
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- LPH
- PMA / PMN Number
- K974093
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE PT HAD AN ENCORE LINER WITH A METAL TRIM. THE METAL HEAD WORE THROUGH THE POLY AND BEGAN RUBBING ON THE METAL SHELL CAUSING FRAGMENTS TO FLAKE OFF INTO THE PT. THE SURGEON EXCHANGED LIKE ENCORE LINER WITH A NEW NON-HOODED HIGHLY CROSS LINKED (HXL) POLY LINER. THE HEAD WAS REMOVED AND REPLACED WITH A SMITH AND NEPHEW METAL HEAD DESIGNED FOR PTS WITH METAL ALLERGIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 381136 | FMP HIP | HEMISPHERICAL SHELL W/SCREWHOLES | LPH | ENCORE MEDICAL, L.P. | 256952 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4), LOT 243902| (B)(4), LOT 243492| (B)(4), LOT 254162 |