FDA Adverse Event
Injury
Summary report: N
UNKNOWN FEMORAL HEAD
MDR report key: 3173881
·
Received June 17, 2013
Report
- Report Number
- 1818910-2013-19069
- Event Type
- Injury
- Date Received
- June 17, 2013
- Date of Event
- June 12, 2013
- Report Date
- June 12, 2013
- Manufacturer
- DEPUY INTL., LTD. - 8010379
- Product Code
- KWY
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
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 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
LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM ELEVATED LEVELS OF CHROMIUM AND COBALT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274388 | UNKNOWN FEMORAL HEAD | FEMORAL HEAD | KWY | DEPUY INTL., LTD. - 8010379 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other |