ARTICULEZE M HEAD 36MM +8.5
Report
- Report Number
- 1818910-2014-31507
- Event Type
- Injury
- Date Received
- November 11, 2014
- Date of Event
- January 15, 2015
- Report Date
- January 23, 2015
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- JDI
- PMA / PMN Number
- PK980513
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
ADDITIONAL NARRATIVE: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: UNAVAILABLE. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE.
ADDITIONAL NARRATIVE: THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).
ADDITIONAL NARRATIVE: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.
DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
UDI: (B)(4).
UPDATE 11/25/2015- PFS AND MEDICAL RECORDS RECEIVED. PFS WAS AMENDED AND REPORTED GRINDING, THROBBING, LIMITED RANGE OF MOTION AND DIFFICULTY STANDING AND WALKING. IT ALSO REPORTED THAT THE FRACTURES WERE RELATED TO A MOTOR VEHICLE ACCIDENT. THE MEDICAL RECORDS AND REVISION SURGICAL REPORT NOTED CRUNCHING, GRINDING, METAL HYPERSENSITIVITY, CHRONIC INFLAMMATION, SMALL EFFUSION AND NO CLINICAL SIGN OF INFECTION. THERE WAS NO LAB RESULTS OR REPORTS OF METAL ION LEVELS WITHIN THE MEDICAL RECORDS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: DEC 16, 2015.
UPDATE RECEIVED 1/15/15. THE SALES REP REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO DUE TO ELEVATED ION LEVELS. COMPLAINT WAS UPDATED ON 2/3/15.
UPDATE 5/4/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS NO LAB RESULTS HAVE BEEN PROVIDED FOR THE ALLEGED HIGH METAL IONS. MEDICAL RECORDS INDICATE THE PATIENT SUFFERED A CLOSED FRACTURES OF THE FEMUR AND ACETABULUM. THERE IS SOME DATE DISCREPANCY AS SOME RECORDS INDICATE IT OCCURED DURING A MVA (BEFORE DOI) AND OTHER RECORDS INDICATE THE FRACTURES OCCURRED IN 2008 (UNKNOWN REASON). IF/WHEN WE RECEIVE MORE INFORMATION WE WILL UPDATE AS NEEDED. THE COMPLAINT WAS UPDATED ON: 5/26/2015.
UPDATE 1/23/15 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, NO LAB RESULTS HAVE BEEN PROVIDED FOR THE ALLEGED HIGH METAL IONS.
LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN.
IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR AND METALLOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 727388 | ARTICULEZE M HEAD 36MM +8.5 | HIP FEMORAL HEAD | JDI | DEPUY ORTHOPAEDICS INC US | 2075908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Required Intervention |