AMBI-COMPRESSION HIP SCREW
Report
- Report Number
- MW4003197
- Event Type
- Injury
- Date Received
- February 2, 2002
- Date of Event
- February 26, 2001
- Manufacturer
- SMITH & NEPHEW
- Product Code
- KTT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
AMBI COMPRESSION HIP SCREW WITH 3 HOLE PLATE WITH ONLY TWO SCREWS INSERTED. "CORRECTION LEGAL NOTICE" TRUE MANUFACTURER NAME. SMITH NEPHEW INC. PRODUCT LIABILITY DEVICES.
ADD'L INFO RECEIVED 7/21/03: PT, THE USED OF DEVICE IS AT A SUBSTANTIAL RISK OF DYING BECAUSE OF SUSPECTED MALFUNCTION. VIEWED X-RAY'S. THE 12.7MM COMPRESSION SCREW MOVED OUTWARD 1 3/4. THE LOWER PLATE HIGH RISK OF BREAKING THE TWO SCREWS HOLDING PLATE. THEY HAVE EXTREME PAINS, FEVER, COLD SWEATS AND TROUBLE WALKING. GRINDING OF FEMORAL HEAD IN PELVIC SOCKET. SCREW HEAD BOBBING AND RUBBING THIGH MUSCLE TISSUE. HOSPITAL ORTHO-DECISION: REMOVE HARDWARE AND LEAVE PT WITH OUT TOTAL JOINT REPLACEMENT. PT DECISION-"JOINT REPLACEMENT ARE NO SURGERY." TRAUMA RELATED DISORDER-DEVELOPING OSTEONECROSIS IN FEMORAL HEAD. WITH LACK OF BLOOD SUPPLY, FEMORAL HEAD IS DYING BONE BREAKING-UP CAUSING RUBBING AND GRINDING OF CARTILAGE ON FEMORAL HEAD.
IN 2001 RPTR HAD ORTHOPAEDIC SURGERY AT 9:36. DIAGNOSIS: RIGHT LOWER LOBE ATELECTASIS. O.R.I.F HARDWARE, LOCATION OF SVC IN LEFT LEG. COMPLETE HIP REPLACEMENT. UNFORTUNATELY THEY REPAIRED WITH THE PRODUCT O.R.I.F_HARDWARE. THE PRODUCT, AND THEIR MEDICAL ADVICE, HAS NOT PERFORMED WELL, SVC WAS INADEQUATE. BECAUSE (IN STATING THE PROBLEM) RPTR IS DISAPPOINTED BECAUSE THE PRODUCT DOES NOT WORK AS HIP REPLACEMENT. RPTR LIVES TRAUMA DAILY BECAUSE OF PRODUCT. HIP REPLACEMENT WAS MISREPRESENTED. RPTR HAS MATERIAL EVIDENCE. HIP REPLACEMENT SURGERY INVOLVED OSTEOTOMY IN SURGICAL REPOSITIONING OF THE JOINT. THE SURGEON CUTS AWAY DAMAGED BONE AND TISSUE AND RESTORES THE JOINT TO ITS PROPER POSITION AND CORRECT POSITION WHERE THE UPPER END OF THE FEMUR MEETS THE ACETABULUM, (THE FEMUR, OR THIGH BONE) WHERE MEETS THE SOCKET OF THE PELVIS (AREA OF NATURAL GLIDING MOTION OF THE JOINT). EVIDENCE OF O.R.I.F HARDWARE. THE ARRANGEMENT DOESN'T ALLOW A WIDE RANGE OF MOTION, INCLUDING SITTING, STANDING, WALKING AND OTHER DAILY ACTIVITIES, BECAUSE HARDWARE LEAVES DAMAGED BONE AND MUSCLE TISSUE. THE O.R.I.F HARDWARE MATERIAL LEAVES RPTR'S LEFT LEG SHORTER THAN RIGHT LEG BY 1 1/2. UPDATED MEDICAL CONDITION: INCORRECT POSITION OF HIP JOINT. TRAUMA SUFFERED DAILY SINCE ORTHOPAEDIC SURGERY IN 2001. ADDITIONAL PAPERWORK RECEIVED ON 1-13-05. THE DOCUMENTS WILL BE IMAGED. ON 4/14/05 ADD'L INFO REC'D WILL BE IMAGED. ADD'L INFO REC'D 6/28/05 TO BE IMAGED. ADD'L INFO REC'D 12/20/04 TO BE IMAGED. ADD'L INFO REC'D 8/2/05 TO BE IMAGED. ADD'L INFO REC'D 8/9/05 TO BE IMAGED. ADD'L INFO REC'D 9/20/05 TO BE IMAGED. ADD'L INFO REC'D 5/19/06 TO BE IMAGED.
ADD'L INFO REC'D 2/15/05 WILL BE IMAGED. VENT JOINT PAIN WITH ATTEMPTED MOTION. PRODUCT PROBLEM UPON PRODUCT ASSEMBLY TWO SCREW INSERTED IN A 3 HOLE PLATE WITH A UNK SCREW INSERTED BESIDE HIP SCREW. X-RAYS VIEW DEVICE. PRESCRIPTION BY.
PT'S CONDITION AS OF 07/2003: NO COMMUNICATIONS WITH ALL THREE ALLIED DISTRIBUTORS OF DEVICE. EXTREME PAINS, TROUBLE WALKING, STANDING, SITTING, FEVERS, COLD-SWEATS.
PT HAS HIP PAIN WITH ALL ATTEMPTED MOTION. HIP JOINT POPS ON EVERY ATTEMPT OF MOTION. THERE IS 1 1/2 SLACK IN JOINT AREA BECAUSE OF LEG SHORTENING. SUSPECTED MALFUNCTION. SCREW ADVANCED OUTWARD, 1 3/4 INTO THIGH MUSCLE TISSUE. CAUSES PAIN AND SWELLING WHILE RUBBING RAW TISSUE. PT DECISION. TOTAL JOINT REPLACEMENT ARE "NO". HIP SURGERY. DUE TO A SERIES OF COMPLICATIONS AND SERIOUS CONSEQUENCES THAT ARE LIFE-THREATENING. RELATED TRAUMA DISORDER - OSTEONECROSIS DEVELOPING IN FEMORAL HEAD WITH A SERIES OF INFECTIONS. CORRECTIVE HIP SURGERY WOULD PREVENT IT. SURGEON DECISION - WOULD SET PT UP FOR A VASCULAR-NECROSIS OF HIP FEMORAL JOINT. WHICH COULD CAUSE THEIR DEATH. ADD'L INFO REC'D 07/11/2003: PT'S CONDITION AS OF 7/2003: EXTREME PAINS, TROUBLE WALKING, STANDING, SITTING, FEVERS, COLD-SWEATS. NO COMMUNICATIONS WITH ALL THREE ALLIED DISTRIBUTORS OF DEVICE. ADD'L INFO REC'D 7/21/2003: PT, THE USER OF DEVICE IS AT A SUBSTANTIAL RISK OF DYING BECAUSE OF SUSPECTED MALFUNCTION. VIEWED X-RAYS. THE 12.7MM COMPRESSION SCREW MOVED OUTWARD 1 3/4. THE LOWER PLATE HIGH RISK OF BREAKING THE TWO SCREWS HOLDING PLATE. THEY HAVE EXTREME PAINS. FEVER, COLD SWEATS AND TROUBLE WALKING. GRINDING OF FEMORAL HEAD IN PELVIC SOCKET. SCREW HEAD BOBBING AND RUBBING THIGH MUSCLE TISSUE. HOSPITAL ORTHO-DECISION: REMOVE HARDWARE AND LEAVE PT WITHOUT TOTAL JOINT REPLACEMENT. PT DECISION-"JOINT REPLACEMENT ARE NO SURGERY." TRAUMA RELATED DISORDER-DEVELOPING OSTEONECROSIS IN FEMORAL HEAD. WITH LACK OF BLOOD SUPPLY, FEMORAL HEAD IS DYING BONE BREAKING-UP CAUSING RUBBING AND GRINDING OF CARTILAGE ON FEMORAL HEAD. ADD'L INFO REC'D 07/24/2003: AN UNKNOWN SCREW INSERTED. AMBI. THREE HOLE COMPRESSION HIP SCREW PLATE HAS ONLY TWO SCREWS INSERTED IN IT. ACCORDING TO X-RAYS VIEW THE OUTSIDE ADJUSTMENT SCREW HAS MOVED OUTWARD, BUT HOSPITAL WON'T GIVE REPORTER CORRECTIVE SURGERY. REPORTER RESEARCHED THROUGH MEDICAL LIBRARY AND IT IS REQUIRED THAT HOSPITAL FOLLOW THE MFR SYSTEM REGULATION WHEN INSERTING CORTEX SCREWS. ADD'L INFO ADDED THROUGH 4 SEPARATE FOLLOW-UPS DATED 09/11/03, 09/23/03, 10/17/03, 10/20/03. MFR WON'T COMMUNICATE OR MONITOR DEVICE. THE NUMBER OF ADD'L PAGES OF THE 4 FOLLOW-UPS IS 188 (72, 36, 40, 40). ADD'L PAGES FOR FOLLOW-UP PM DATE 10/28/2003 IS 144. ADD'L INFO REC'D FROM RPTR 11/14/03: ADD'L PAGES REC'D 11/14/03 IS 7. ADD'L INFO REC'D FROM RPTR 12/8/03. ADD'L PAGES REC'D 12/8/03 IS 5. ADD'L INFO REC'D FROM RPTR 12/17/03. ADD'L PAGES REC'D 12/17/03 IS 3. ADD'L INFO REC'D FROM RPTR 02/09/04. ADD'L PAGES REC'D 02/09/04 IS 2. ADD'L INFO REC'D FROM RPTR 02/11/04. ADD'L PAGES REC'D 02/11/04 IS 3. ADD'L PAGES REC'D 03/03/04 IS 12. ADD'L PAGES REC'D 03/10/04 IS 2. ADD'L PAGES REC'D 03/11/04 IS 8. ADD'L PAGES REC'D 03/15/04 IS 8. ADD'L PAGES REC'D 04/06/04 IS 2. ADD'L INFO REC'D 2/15/05 AND 2/23/05 WILL BE IMAGED. ADD'L INFO REC'D 5/12/05 WILL BE IMAGED.
ADD'L INFO REC'D FROM RPTR 6/6/02: RPTR HAS A SERIOUS CHANGE IN MEDICAL CONDITION DUE TO MEDICAL EQUIPMENT. O.R.I.F. HARDWARE. MEDICAL CONDITION CHANGE IS: HEAVIER EXTREME PAINS. THE BOLT IS RUBBING AND JOBBING AND CUTTING FLESH OF THIGH MUSCLE TISSUE CAUSING EXTREME SWELLING AND BLEEDING OF MUSCLE TISSUE WHILE RPTR IS TRYING TO WALK OR STAND AND TRYING TO SIT DOWN. BUT WHEN RPTR IS TRYING TO WALK THE BALL ON TOP OF FEMUR GRINDS AND SLAMS INTO THE PELVIS SOCKET THROWING THEM OFF BALANCE. DUE TO THE 1 1/2 SLACK IN BETWEEN BALL AND PELVIS SOCKET RPTR CAN'T WALK CORRECTLY. THE ORTHOPAEDIC SURGEONS LEFT THEM THIS WAY FOR LIFE TO LIVE DAILY TRAUMA. DIAGNOSIS: RIGHT LOWER LOBE ATELECTASIS.
REPORTER IS ALSO AWARE THAT SYNTHES U.S.A. MFR IS RESPONSIBLE FOR PREDICATE DEVICE. REPORTER ALSO WANTS THE F.D.A. OFFICE TO BE AWARE THAT THEY HAVE FILED IN THE UNITED STATES DISTRICT COURT. DEFENDANTS THAT IMPLANTED THE VITRO DEVICE. THEY ARE REQUESTING THAT FDA OFFICE SEND SYNTHES MFR A COPY OF THIS COMPLAINT AND RETURN THEM A FILED STAMPED COPY. 510K LEGAL NOTIFICATION. OPERATIVE COMPLICATIONS: VARUS DEFORMITY LEG SHORTENING, IMPLANT BREAKAGE, IMPLANT LOOSENING, DISASSEMBLY OF IMPLANT, URINARY INFECTION, DEEP WOUND INFECTION, EXTERNAL ROTATION THIGH OR HIP TENDERNESS, BLOOD LOSS, UNSTABLE WALKING/STANDING/SITTING. UNSTABLE-SLACK INBETWEEN FEMUR AND PELVIS, THERMAL NECROSIS DUE TO DRILLING, FATIGUED THIGH MUSCLE, FEVERS, COLD SWEATS, PRESSURE SOURS IN THIGH TISSUE, SWELLING OF THIGH MUSCLE TISSUE, BLEEDING OF TISSUE, PROLONGED HEALING, GRINDING CARTILAGE TISSUE. TOP FEMUR, ARTHRITIS HIP BEGINS. ADD'L INFO REC'D 5/12/05 WILL BE IMAGED.
REPORTER IS REQUESTING ENFORCEMENT IN MEDWATCH COMPLAINT. THERE IS A REASONABLE PROBABILITY THAT THE USE OF THE DCL SYSTEM "ARE MATERIAL BREAK DOWN", THIS KNOWN VIOLATIVE PRODUCT WILL CAUSE SERIOUS ADVERSE HEALTH CONSEQUENCES, IT IS LIFE-THREATENING WHEN DEVICE LOWER PLATE HAS ONLY TWO SCREWS INSERTED. IT HAS A RELATIVE DEGREE OF HEALTH HAZARD THAT WILL CAUSE THEIR DEATH.
NEW MEDICAL CONDITION DATE. PT IS DEVELOPING OSTEONECROSIS IN FEMORAL HEAD OF FEMUR. PT IS HAVING TROUBLE WITH JOINT RANGE OF MOTION, INCLUDING WALKING, STANDING, SITTING, FEVERS AND COLD SWEATS. PT IS REQUESTING ENFORCEMENT IN COMPLAINT.
ADD'L INFO REC'D 12/23/2005 WILL BE IMAGED. FACT NO WARNING OF CAUTION STATEMENTS .21 CFR 201.6 MISLEADING. EVENT JOINT PAIN WITH ATTEMPTED MOTION. PRODUCT PROBLEM TWO SCREWS IN A 3 HOLE AMBIPLATE..RQ'S 3 SCREWS AND X-RAYS VIEW UNK SCREW INSERTED BESIDE AMBI.
X-RAY VIEW; SUSPECTED MALFUNCTION, LOOSENING OF 12.7MM ARE 100MM COMPRESSION SCREW. DR NOTED SCREW HEAD MOVING OUTWARD 1 3/4. DR NOTED: REMOVE HARDWARE WITHOUT TOTAL JOINT REPLACEMENT. PT DECISION: NO SURGERY, BECAUSE PT IS DEVELOPING OSTEONECROSIS IN FEMORAL HEAD. TO PREVENT PROBLEM, CORRECTIVE JOINT REPLACEMENT. DEVICE IMPLANTED IN LEFT FEMUR. X-RAYS VIEW AT UNIT.
ADD'L INFO RECEIVED 7/11/03: PT CONDITION AS OF 7/2003: NO COMMUNICATIONS WITH ALL THREE ALLIED DISTRIBUTORS OF DEVICE. EXTREME PAINS, TROUBLE WALKING, STANDING, SITTING, FEVERS, COLD SWEATS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMBI-COMPRESSION HIP SCREW | SLIDING HIP SCREW WITH 3 HOLE PLATE | KTT | SMITH & NEPHEW | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Life Threatening| R |