FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPL SIZE 45
MDR report key: 1933657
·
Received December 17, 2010
Report
- Report Number
- 1818910-2010-09926
- Event Type
- Injury
- Date Received
- December 17, 2010
- Date of Event
- August 24, 2010
- Report Date
- November 17, 2010
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
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 PAIN AND DISCOMFORT. MEDICAL RECORDS WERE RECEIVED AND INDICATED LARGE CYST GENERATION AND PRESENCE OF A CREAMY, WHITE BUILD-UP OF MATERIAL IN THE JOINT. ADDITIONALLY, PRODUCT AND LOT NUMBERS WERE IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR UNI FEMORAL IMPL SIZE 45 | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | 2768759 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |