FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPL SIZE 46
MDR report key: 3885258
·
Received June 19, 2014
Report
- Report Number
- 1818910-2014-21556
- Event Type
- Injury
- Date Received
- June 19, 2014
- Date of Event
- November 15, 2010
- Report Date
- June 10, 2014
- Manufacturer
- DEPUY INTERNATIONAL LTD.-8010379
- Product Code
- KWA
- PMA / PMN Number
- PK040627
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
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. REF. (B)(4). DEPUY CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
ASR REVISION REPORTED VIA SALES REP. LEFT. REASON(S) FOR REVISION : NOISE / WEAKNESS / ALTR / PAIN / HIGH CHROMIUM LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361564 | ASR UNI FEMORAL IMPL SIZE 46 | HIP FEMORAL HEAD | KWA | DEPUY INTERNATIONAL LTD.-8010379 | 2533915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |