ASR UNI FEMORAL IMPL SIZE 49
Report
- Report Number
- 1818910-2011-05579
- Event Type
- Injury
- Date Received
- April 6, 2011
- Date of Event
- March 8, 2011
- Report Date
- May 1, 2015
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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.
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 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.
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 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.
UPDATE REC'D 5/1/2015 - PPD AND MEDICAL RECORDS RECEIVED. PPD AND MEDICAL RECORDS WERE RECEIVED ON 12/2/2013 WITH THE ALERT DATE OF (B)(6) 2013. THESE RECORDS WERE REVIEWED FOR MDR REPORTABILITY ON 5/1/2015. THE PRIMARY OPERATIVE NOTE ON (B)(6) 2007 INDICATED HAD A PREVIOUS HIP IMPLANTATION THAT WENT SEPTIC. THE MANUFACTURER OF THE IMPLANTS IS UNKNOWN AND THIS PREVIOUS SURGERY ISN'T INCLUDED IN THE PPD. THE REVISION OPERATIVE NOTE INDICATED PAIN AND LOOSE CUP. THERE WAS NO MENTION OF CLICKING/POPPING/GRINDING SOUNDS, INFECTION, OR METALLOSIS. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS.
LITIGATION PAPERS ALLEGE THE PT SUFFERED SYMPTOMS AND DAMGE TO HER BODY INCLUDING BUT NOT LIMITED TO SEVERE PAIN AND DISCOMFORT IN HER GROIN, THIGH, AND HIP; CLICKING, GRINDING AND POPPING OF THE IMPLANT WHEN SHE WALKED AND WENT TO AND FROM A SITTING POSITION; INFECTION AND INFLAMMATION OF BONE AND TISSUE SURROUNDING THE IMPLANT; METALLOSIS; LACK OF MOBILITY; AND CHROMIUM AND COBALT METAL TOXICITY. PT IS A RESIDENT OF WI. UPDATE (B)(6) 2011 - NEW INFO RECEIVED. PT REVISED (B)(6) 2011 TO ADDRESS PAINFUL, POSSIBLY LOOSE ASR CUP, WITH NO INGROWTH ON IMPLANT. RECEIVED PART/LOT INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR UNI FEMORAL IMPL SIZE 49 | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | 2337025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |