FDA Adverse Event
Injury
Summary report: N
11/13 S-ROM 40MM M SPEC+3
MDR report key: 2970377
·
Received February 20, 2013
Report
- Report Number
- 1818910-2013-12634
- Event Type
- Injury
- Date Received
- February 20, 2013
- Date of Event
- September 10, 2010
- Report Date
- January 31, 2013
- Manufacturer
- DEPUY IRELAND ¿ REG. # 9616671
- Product Code
- LPH
- PMA / PMN Number
- PK060031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- ATTORNEY
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.
Additional Manufacturer Narrative · 1
DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
LITIGATION ALLEGES THAT THE PATIENT SUFFERS SERIOUS BODILY INJURY AND PAIN. UPON REVISION, METALLOSIS AND BLACK FLUID WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74027 | 11/13 S-ROM 40MM M SPEC+3 | FEMORAL HEAD | LPH | DEPUY IRELAND ¿ REG. # 9616671 | 2414026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |