FDA Adverse Event
Injury
Summary report: N
TOTAL ASR FEM IMP SIZE 41
MDR report key: 1903123
·
Received November 17, 2010
Report
- Report Number
- 1818910-2010-08440
- Event Type
- Injury
- Date Received
- November 17, 2010
- Date of Event
- June 8, 2010
- Report Date
- April 23, 2026
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
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. THIS IMPLANT IS NOT SOLD IN THE US TO BE IMPLANTED FOR THIS INDICATION; IT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER AS IT IS INDICATED ONLY TO BE USED AS A HEMI IN THE US AT THIS TIME.
Description of Event or Problem · 1
REVISED DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTAL ASR FEM IMP SIZE 41 | TOTAL HIP PROSTHESIS | KWY | DEPUY INTERNATIONAL, LTD. | NA | 2079106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |