FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPL SIZE 46
MDR report key: 3030107
·
Received April 2, 2013
Report
- Report Number
- 1818910-2013-06463
- Event Type
- Injury
- Date Received
- April 2, 2013
- Date of Event
- March 21, 2013
- Report Date
- June 19, 2013
- 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
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.
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 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 METALLOSIS.
Description of Event or Problem · 1
UPDATE: 06/19/2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM CHROMIUM AND COBALT POISONING AND PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134725 | ASR UNI FEMORAL IMPL SIZE 46 | FEMORAL HEAD | KWA | DEPUY INTERNATIONAL | 2334137 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |