FDA Adverse Event
Injury
Summary report: N
ASPHERE M SPEC 12/14 36 +5
MDR report key: 1972484
·
Received January 26, 2011
Report
- Report Number
- 1818910-2011-00985
- Event Type
- Injury
- Date Received
- January 26, 2011
- Date of Event
- December 27, 2010
- Report Date
- December 27, 2010
- Manufacturer
- DEPUY INTL LTD.
- Product Code
- KWA
- PMA / PMN Number
- K082585
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASPHERE M SPEC 12/14 36 +5 | 87KWA; 87 JDI; 87LPH | KWA | DEPUY INTL LTD. | NA | 3224295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |