FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPL SIZE 45
MDR report key: 3183366
·
Received June 21, 2013
Report
- Report Number
- 1818910-2013-19591
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- June 17, 2013
- Report Date
- June 17, 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
- TX, 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. (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.
Additional Manufacturer Narrative · 1
THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS CONSIDERED CLOSED.
Description of Event or Problem · 1
LITIGATION PAPERS RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN, LIMITED RANGE OF MOTION, AND ELEVATED METAL ION LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283626 | ASR UNI FEMORAL IMPL SIZE 45 | TOTAL HIP REPLACEMENT | KWA | DEPUY INTL., LTD. - 8010379 | 2005208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |