S-ROM*SLEEVE PRX ZTT, 20F-LRG
Report
- Report Number
- 1818910-2016-12140
- Event Type
- Injury
- Date Received
- January 28, 2016
- Date of Event
- September 30, 2016
- Report Date
- March 13, 2017
- Manufacturer
- DEPUY IRELAND 9616671
- Product Code
- LPH
- PMA / PMN Number
- PK934412
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- ATTORNEY
Narratives
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, 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.
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 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. (B)(4).
DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.
DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.
UPDATE 5/27/16-PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. MEDICAL RECORDS REPORTED THAT LAB RESULTS FOR METAL IONS WERE LESS THAN 7 PARTS PER BILLION, PATIENT STILL HAS NOT BEEN REVISED AND HAD A STRESS FRACTURE OF THE RIGHT FEMUR AT THE MIDSHAFT ON (B)(6) 2015 AND THAT THE STEM WAS NO LOOSE. RADIOGRAPHS REPORTEDLY SHOWED MILD VARUS POSITION WITH SIGNIFICANT VARUS REMODELING OF THE FEMORAL COMPONENT. PATIENT HARMS UPDATED FOR STRESS FRACTURE. THE COMPLAINT WAS UPDATED ON: JUN 13, 2016.
PATIENT CORRESPONDENCE: PATIENT SUBMITTED MAUDE REPORT (MW-5042834) STATING THE FOLLOWING: "IN 2004, I WAS DIAGNOSED WITH AVASCULAR NECROSIS, A RARE HIP DISORDER THAT CAUSED BOTH MY HIPS TO DRYUP AND CRUMBLE. I HAD ONE HIP REPLACED IN 2004 AND THE OTHER HIP REPLACED IN 2013. I NEED TO HAVE THE ORIGINAL HIP REPLACED DUE TO BEING DIAGNOSED WITH METALLOSIS. THIS IS A CONDITION IN WHICH A JOINT IMPLANT SLOWLY RELEASES COBALT INTO THE BLOOD. CURRENTLY, THERE ARE CASES GOING TO TRIAL FOR MY EXACT HIP THAT WAS PUT INSIDE MY BODY A DEPUY-PINNACLE JOHNSON AND JOHNSON. THERE ARE THOUSANDS OF PEOPLE NATIONWIDE SUFFERING FROM THE SAME ILLNESS BUT, UNFORTUNATELY WE ARE YEARS AWAY FROM THE MAKER OF THIS DEVICE. THIS CONDITION MAKES IT SO I AM UNABLE TO WORK AND VERY SICK AT TIMES. I WAS AWARDED IN 2012, BUT ENDED MY CLAIM AND TRIED WORKING FOR 10 MONTHS. I FAILED AT THAT ATTEMPT AND HAD MY SECOND HIP REPLACED IN 2013 AND HAVE LOST ALL BENEFITS. TODAY I HAVE NO INCOME AND CONTINUE TO BE DENIED MEDICAID FOR OVER THE PAST 15 MONTHS FOR NOT HAVING A QUALIFYING CHILD OR CLASSIFIED DISABLED. I HAVE RE-APPLIED FOR DISABILITY AND AM WAITING FOR MY HEARING. IN THE MEANTIME, I AM GETTING SICKER EVERY DAY. I AM LOSING FEELING (NEUROPATHY) IN MY HANDS AND FEET, I AM LOSING THE ABILITY TO DRIVE, RELYING ON OTHERS TO HELP ME GET THROUGH EACH DAY. I AM TAKING MENTAL HEALTH MEDICATIONS THAT MY DOCTORS AND ARNP'S BELIEVE TO BE A RESULT OF SAID METALLOSIS. IF I WAS A DOG ON THE NEWS TONIGHT SUFFERING FROM THIS ILLNESS I WOULD HAVE BEEN RESCUED AND SAVED. UNTIL THEN CARED FOR WITH TAX DOLLARS. BUT I AM NOT, I AM A AMERICAN MALE THAT HAS WORKED SINCE AGE (B)(6). I HAVE BEEN SICK FROM THIS FOR OVER 6 YEARS AND IT TOOK UNTIL THIS YEAR TO FIND IT. WHAT IS IT GOING TO TAKE TO GET ONE MAN WHO IS VERY SICK THE HELP HE NEEDS TO GET BETTER AND START WORKING. I AM A POSITIVE GUY; I KNOW I WILL SURVIVE THIS BUT THE MENTAL AND PHYSICAL DAMAGE IS TAKING ITS TOLL ON ME AND WHAT IS LEFT OF THOSE WHO CARE FOR ME. PLEASE FORWARD THIS TO APPROPRIATE PEOPLE OR DEPARTMENT FOR REVIEW AND ASSISTANCE." DUE TO THE PATIENT REQUESTING COMPENSATION, THE EMAIL IS BEING FORWARDED TO (B)(6) IN THE LEGAL GROUP. UPDATE REC'D 08/04/2015 - PER (B)(6) IN THE LEGAL GROUP, THE REQUEST FOR COMPENSATION IS NOT CLEAR. THEREFORE, THE COMPLAINT HANDLING UNIT CAN HANDLE FOLLOW-UP REQUESTS. DOI: (B)(6) 2004 - DOR: NONE REPORTED (UNK HIP). UPDATE REC'D 09/14/2015 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND METALLOSIS. LITIGATION INDICATED ALLEGATIONS FOR THE RIGHT HIP. THE UNKNOWN HIP IS BEING REPORTED AS A LINER, AND A HEAD IS BEING ADDED TO ADDRESS ALLEGATIONS OF METAL ON METAL. UPDATE 01/05/2016 - PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PFS REPORTED RIGHT HIP PAIN, ABNORMAL GAIT AND INCREASED COBALT. MEDICAL RECORDS REPORTED LEFT HIP THA IN 2013, RIGHT HIP WITHOUT REVISION, LIMITED RANGE OF MOTION, FAILURE OF FIXATION OF RIGHT SIDE FEMORAL COMPONENT AND VARUS ALIGNMENT OF THE RIGHT FEMORAL COMPONENT. METAL ION LAB RESULTS WERE LESS THAN 7 PARTS PER BILLION AND NO REPORT OF METALLOSIS WITHIN MEDICAL RECORDS REVIEWED. STEM AND SLEEVE ADDED FOR LOOSENING. PART/LOT UPDATED. THE COMPLAINT WAS UPDATED ON: JAN 27, 2016.
UPDATE (3/13/2017) MEDICAL RECORDS RECEIVED. AFTER THOROUGH REVIEW OF THE MEDICAL RECORDS, THERE CONTINUES TO BE NO RECORD OF RIGHT HIP REVISION. THERE IS NO NEW INFORMATION THAT WOULD AFFECT EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 4/5/2017.
UPDATE 12/08/2016 ¿ PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, LAB VALUES STILL INDICATE THE METAL ION LEVELS ARE BELOW 7PPB. NO DATE OF REVISION HAS BEEN PROVIDED STILL. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION.
LITIGATION ALLEGES DIFFICULTY IN WALKING LONG DISTANCE, FATIGUE AND ABNORMAL GAIT. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PROGRESSIVE THIGH PAIN. REVISION NOTE STATED, THERE WAS NO SIGN FOR ANY INFECTION. CORROSION WAS PRESENT IN THE TRUNION. X-RAY SHOW MALPOSITION OF THE FEMORAL COMPONENT IN VARUS. LABORATORY VALUES FOR COBALT/CHROMIUM LEVELS ARE BELOW 7 PPB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56022 | S-ROM*SLEEVE PRX ZTT, 20F-LRG | HIP FEMORAL STEM/SLEEVE | LPH | DEPUY IRELAND 9616671 | 1165713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |