FDA Adverse Event
Injury
Summary report: N
12/14 ARTICUL 40MM M SPEC+5
MDR report key: 1962492
·
Received January 7, 2011
Report
- Report Number
- 1818910-2011-00239
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 10, 2010
- Report Date
- December 10, 2010
- Manufacturer
- DEPUY INTL., LTD.
- Product Code
- LPH
- PMA / PMN Number
- K060031
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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
PATIENT REVISED TO ADDRESS INFECTION. DID WASHOUT AND REMOVED HEAD, CUP WAS MFG BY OTHERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 12/14 ARTICUL 40MM M SPEC+5 | 87 LPH, JDI | LPH | DEPUY INTL., LTD. | NA | 3070340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |