FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPL SIZE 43
MDR report key: 2840593
·
Received November 20, 2012
Report
- Report Number
- 1818910-2012-27439
- Event Type
- Injury
- Date Received
- November 20, 2012
- Date of Event
- March 21, 2011
- Report Date
- February 27, 2026
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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). 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
PATIENT WAS REVISED TO ADDRESS HIP PAIN AND ACETABULAR LOOSENING. ON (B)(6) 2012 - PATIENTS OPERATIVE RECORDS RECEIVED. IT WAS NOTED THE PATIENT HAD A FAIR AMOUNT OF BROWN FLUID UNDER PRESSURE IN THEIR HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR UNI FEMORAL IMPL SIZE 43 | FEMORAL HEAD | KWA | DEPUY INTERNATIONAL | 2795364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |