FDA Adverse Event
Injury
Summary report: N
SROM STM STD 36+12L 15X20
MDR report key: 2934753
·
Received January 30, 2013
Report
- Report Number
- 1818910-2013-02033
- Event Type
- Injury
- Date Received
- January 30, 2013
- Report Date
- June 19, 2013
- Manufacturer
- DEPUY WARSAW
- Product Code
- LPH
- PMA / PMN Number
- K851422
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.
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
THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4).
Description of Event or Problem · 1
LITIGATION ALLEGES PATIENT HAD PAIN, WEAKNESS, DIFFICULTY WITH SIMPLE DAILY LIVING ACTIVITIES, LEG LENGTH INEQUALITY AND INCREASED METALLIC IONS IN BLOODSTREAM AFTER ASR HIP IMPLANT.
Description of Event or Problem · 1
UPDATE: (B)(6) 2013 - SALES REP REPORTED REVISION OF RIGHT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41531 | SROM STM STD 36+12L 15X20 | STEM - HIP IMPLANT | LPH | DEPUY WARSAW | 2906856 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |