ADAPTER SLEEVES 12/14 +5
Report
- Report Number
- 1818910-2011-08514
- Event Type
- Death
- Date Received
- May 13, 2011
- Date of Event
- February 3, 2007
- Report Date
- May 20, 2015
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- PK040627
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- ATTORNEY
Narratives
**UPDATE** (B)(6) - UPDATED LITIGATION ALLEGES PATIENT SUFFERED CONSTANT, SEVERE PAIN; INABILITY TO SIT DOWN FOR PROLONGED PERIODS OF TIME; ELEVATED BLOOD LEVELS OF COBALT WHICH WERE CONFIRMED BY TESTS TAKEN ON OR ABOUT (B)(6) 2010; MULTIPLE WOUND CLOSURE PROCEDURES; INFECTIONS; REVISION SURGERY; AND DEATH. THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
(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.
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.
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
DEPUY STILL CONSIDERS THIS INVESTIGATON CLOSED.
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(S) AND/OR CORRECTIVE ACTIONS. REF. WWCAPA (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.
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY AND EVIDENCE OF PRODUCT CONTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
LITIGATION PAPERS ALLEGE: ON OR AROUND (B)(6) 2006, THE PT UNDERWENT SURGERY ON HIS LEFT HIP, AT WHICH TIME AN ASR HIP WAS IMPLANTED. ON (B)(6) 2007, THE PT PRESENTED SIGNS OF ACUTE HIP INFECTION. HIS TREATING PHYSICIAN PERFORMED A RADICAL IRRIGATION AND DEBRIDEMENT AND EXCHANGED THE MODULAR NECK AND HEAD COMPONENTS. ON (B)(6) 2007, THE PT PRESENTED WITH ACUTE FEVER AND INCREASED WOUND INFLAMMATION AND DRAINAGE. HE WAS DIAGNOSED WITH STAPH EPIDERMITIS, HE UNDERWENT ANOTHER DEBRIDEMENT AND IRRIGATION AND AGAIN HIS MODULAR COMPONENTS WERE EXCHANGED THE FOLLOWING DAY. ON (B)(6) 2007, THE PT'S PHYSICIAN PERFORMED A WOUND CLOSURE. THE PROCEDURE WAS A SUCCESS, UNTIL (B)(6) 2007, WHEN THE WOUND SPONTANEOUSLY REOPENED WITH FURTHER DRAINAGE. ON (B)(6) 2007, THE PT WAS READMITTED TO THE HOSPITAL WITH FEVER AND PURULENT DRAINAGE. BLOOD TESTS TAKEN ON (B)(6) 2010, REVEALED THE PRESENCE OF ELEVATED LEVELS OF COBALT. ON (B)(6) 2011, THE PT UNDERWENT REVISION SURGERY TO HAVE THE ASR HIP REMOVED.
UPDATE (B)(4) 2012- PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED. AN INVOICE HAS BEEN LOCATED 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.
UPDATE REC'D 5/7/2015- 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 5/7/2015. THE PPD ALLEGES INFECTION. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT 1ST REVISION WAS (B)(6) 2007 (NOT (B)(6) 2007) FOR INFECTION AND ONLY FEMORAL IMPLANT AND SLEEVE WERE REVISED. NO MEDICAL RECORDS WERE PROVIDED FOR THE (B)(6) 2007 REVISION. THE PATIENT UNDERWENT A 2RD REVISION ON (B)(6) 2010 FOR INFECTION AND ALL IMPLANTS WERE REVISED AND SPACERS WERE PLACED. THE DATE OF REIMPLANTATION WAS NOT PROVIDED. NO LABS WERE PROVIDED AT THIS TIME FOR THE ALLEGED HIGH METAL IONS. THE STEM IMPLANTED ON (B)(6) 2006 IS NOW BEING REPORTED FOR THE INFECTION. THIS COMPLAINT WAS UPDATED ON (B)(6) 2015
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTER SLEEVES 12/14 +5 | TOTAL HIP REPLACEMENT | KWA | DEPUY INTERNATIONAL, LTD. | NA | 1973477 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Death| R |