CORAIL 2 NON COL HO SIZE 12
Report
- Report Number
- 1818910-2010-05480
- Event Type
- Injury
- Date Received
- August 25, 2010
- Date of Event
- August 24, 2010
- Report Date
- January 14, 2015
- Manufacturer
- DEPUY FRANCE SAS - 3003895575
- Product Code
- KWA
- PMA / PMN Number
- K042992
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP IS BEING SUBMITTED TO FILL THE GAP IN FOLLOW-UP.
THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP IS BEING SUBMITTED TO FILL THE GAP IN FOLLOW-UP.
THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP IS BEING SUBMITTED TO FILL THE GAP IN FOLLOW-UP.
CORRECTED/UPDATED DATA: B-3 (DATE OF EVENT); B-4 (DATE OF REPORT); B-5 (EVENT DESCRIPTION); G-4 (DATE RECEIVED BY MANUFACTURER). DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UPDATED A1, B3, B4, B5, B6, B7, D1, D2, D3, D4, D7, E1, F10, F11, G1/2, G4, H4, H7, AND H9. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY : 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-001226. ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-001226. ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
THE PATIENT HAD A REVISION ON THE RIGHT HIP. THE REASONS FOR THE REVISION WERE PREVIOUSLY REPORTED IN THE ORIGINAL MEDWATCH.
NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4) REASON FOR ORIGINAL COMPLAINT. ASR FIRST IMPLANTED (B)(6) 2008. PATIENT HAD PAIN, X-RAYS SHOW HIGH METAL WEAR DEBRIS. A REVISION SURGERY IS NECESSARY, THE REVISION IS SCHEDULED FOR (B)(6) 2010. WE RECEIVED A LETTER FROM THE PATIENT'S LAWYER. TRANSLATED FIRST SURGERY REPORT ATTACHED. UPDATE: CONFIRMED REVISION DATE, ADDED CLAIMSUITE REFERENCE AND HIP REVISED, INFORMATION RECEIVED 26 SEPT 2012. ASR XL (RIGHT). UPDATE - ADDED FURTHER REASON FOR REVISION AND HOSPITAL. TAKEN FROM OPERATIVE REPORT AND CLAIMSUITE DATED 14TH JAN 2015. REASON(S) FOR REVISION: PAIN - HIGH VALUES OF METAL IN BLOOD / LARGE NECROSIS OF FEMORAL NECK / HIP PAIN. (B)6) HOSPITAL.
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
PATIENT HAD PAIN, X-RAYS SHOW HIGH METAL WEAR DEBRIS. A REVISION SURGERY IS NECESSARY, THE REVISION IS SCHEDULED FOR (B)(6).2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28119 | CORAIL 2 NON COL HO SIZE 12 | HIP FEMORAL STEM/SLEEVE | KWA | DEPUY FRANCE SAS - 3003895575 | NA | 2350374 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Male | Required Intervention |