FDA Adverse Event
Other
Summary report: N
FOUNDATION SHOULDER
MDR report key: 2001078
·
Received February 16, 2011
Report
- Report Number
- 1644408-2011-00086
- Event Type
- Other
- Date Received
- February 16, 2011
- Date of Event
- February 7, 2011
- Report Date
- February 7, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWS
- PMA / PMN Number
- K003324
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE PATIENT RECEIVED A HEMI-ARTHROPLASTY APPROXIMATELY SIXTEEN MONTHS AGO. THE PATIENT BEGAN TO EXPERIENCE PAIN AND LIMITED RANGE OF MOTION. THE IMPLANTS WERE REMOVED AND A NEW FOUNDATION TSA WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION SHOULDER | PLASMA HUMERAL STEM W/MALE TAPER | KWS | ENCORE MEDICAL, L.P. | 53996906 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |