FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPL SIZE 49
MDR report key: 3070740
·
Received April 22, 2013
Report
- Report Number
- 1818910-2013-06523
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- April 9, 2013
- Report Date
- August 22, 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
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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
DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.
Description of Event or Problem · 1
PATIENT WAS REVISED DUE TO OSTEOLYSIS.
Description of Event or Problem · 1
**UPDATE**(B)(4) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES ELEVATED METAL ION LEVELS AND PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170998 | ASR UNI FEMORAL IMPL SIZE 49 | FEMORAL HEAD | KWA | DEPUY INTERNATIONAL | 2398491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |