FDA Adverse Event
Other
Summary report: N
TURON SHOULDER
MDR report key: 2530339
·
Received April 5, 2012
Report
- Report Number
- 1644408-2012-00175
- Event Type
- Other
- Date Received
- April 5, 2012
- Date of Event
- March 27, 2012
- Report Date
- March 27, 2012
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- HSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE PATIENT HAD AN UNSTABLE TOTAL SHOULDER. THE POSTERIOR WAS DISLOCATING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TURON SHOULDER | PRIMARY HUMERAL STEM | HSD | ENCORE MEDICAL, L.P. | 458G1005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | (B)(4), LOT 878C1029| (B)(4), LOT 54003844 |