FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPL SIZE 46
MDR report key: 3183068
·
Received June 21, 2013
Report
- Report Number
- 1818910-2013-19541
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- June 18, 2013
- Report Date
- June 28, 2013
- Manufacturer
- DEPUY INTL., 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
- CO, 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. (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 UNDERWENT REVISION PROCEDURE DUE TO PAIN AND ELEVATED CHROMIUM AND COBALT LEVELS.
Description of Event or Problem · 1
UPDATE (B)(4) 2013-LITIGATION PAPERS RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM DISCOMFORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283702 | ASR UNI FEMORAL IMPL SIZE 46 | FEMORAL HEAD | KWA | DEPUY INTL., LTD. - 8010379 | 2452394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |