ARTICULEZE M HEAD 36MM +8.5
Report
- Report Number
- 1818910-2012-23433
- Event Type
- Injury
- Date Received
- October 10, 2012
- Report Date
- November 7, 2014
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- JDI
- PMA / PMN Number
- K980513
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- ATTORNEY
Narratives
LITIGATION PAPERS ALLEGE THAT THE PATIENT EXPERIENCES PROGRESSIVELY SEVERE PAIN, SORENESS AND DISCOMFORT AND HAD EXCESSIVELY HIGH METAL ION LEVELS. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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.THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
(B)(4).
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
LITIGATION PAPERS ALLEGE THAT THE PATIENT EXPERIENCES PROGRESSIVELY SEVERE PAIN, SORENESS AND DISCOMFORT AND HAD EXCESSIVELY HIGH METAL ION LEVELS. PATIENT IS A RESIDENT OF (B)(6).
UPDATE 11/7/2014- PPD AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE MEDICAL RECORDS INDICATED THE METAL IONS WERE BELOW 7PPB IN (B)(6) 2012. AT THIS TIME THE TRILOCK STEM ISN'T BEING ADDED FOR THE ALLEGED HIGH METAL IONS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.
UPDATE 20 OCT 2017: LITIGATION RECORD RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED. LITIGATION ALLEGES FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND METAL LINER, AND INFLAMMATION. THIS COMPLAINT WAS UPDATED ON OCT 30, 2017.
PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES TISSUE AND BONE DAMAGE, LIMITED RANGE OF MOTION, WALKING DIFFICULTY AND LIMITED MOBILITY. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESSED SEVERE GROIN AND HIP PAIN. REVISION NOTE REPORTED THAT THERE WAS SOME EBURNATION WITHOUT ANY SIGNIFICANT STRIPING OF THE TRUNION AND IT WAS NOT FELT THAT THE STEM WAS PROBLEMATIC. LABORATORY RESULTS FOR COBALT/CHROMIUM SHOWED BELOW 7 PPB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTICULEZE M HEAD 36MM +8.5 | FEMORAL HEAD | JDI | DEPUY ORTHOPAEDICS INC US | 2844158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |