ASR ACETABULAR CUPS 56
Report
- Report Number
- 1818910-2012-24897
- Event Type
- Injury
- Date Received
- November 14, 2012
- Report Date
- October 22, 2012
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.
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.
LITIGATION ALLEGES PATIENT HAD PAIN AND DISCOMFORT WHICH AFFECTS ABILITY TO WALK, SLEEP AND MOVE; AND ELEVATED METAL LEVELS IN BLOOD AFTER ASR HIP IMPLANT.
LITIGATION ALLEGES PATIENT HAD PAIN AND DISCOMFORT WHICH AFFECTS ABILITY TO WALK, SLEEP AND MOVE; AND ELEVATED METAL LEVELS IN BLOOD AFTER ASR HIP IMPLANT. **UPDATE** (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR ACETABULAR CUPS 56 | TOTAL HIP REPLACEMENT | KWA | DEPUY INTERNATIONAL | 2610291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |