4.5MM TI BROAD LCP® PLATE 12 HOLES/224MM
Report
- Report Number
- 2520274-2017-11152
- Event Type
- Injury
- Date Received
- April 3, 2017
- Report Date
- March 17, 2017
- Manufacturer
- JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.
- Product Code
- HRS
- PMA / PMN Number
- K000682
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
PATIENT HEIGHT REPORTED AS 158 CENTIMETERS. A PRODUCT INVESTIGATION WAS COMPLETED: NO MATERIAL RECEIVED FOR INVESTIGATION. THE RECEIVED X-RAYS/PICTURES SHOW THAT THE IMPLANT IS BROKEN INSIDE THE BODY; THE COMPLAINT THEREFORE HAS BEEN DETERMINED TO BE CONFIRMED. THE AVAILABLE X-RAYS/PICTURES DO NOT ALLOW ANY DETERMINATION OF THE BREAKAGE ROOT CAUSE OF THE IMPLANT. THE DEVICE HISTORY RECORD REVIEW SHOWS THAT THE DEVICE MET THE SPECIFICATIONS AT THE TIME OF MANUFACTURING AND DISTRIBUTING. NO MATERIAL RECEIVED; WITHOUT PRODUCT INVESTIGATIONS A ROOT CAUSE CANNOT BE DEFINED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODE USED KTT. (B)(4). SOMETIMES IN (B)(6) 2016. EXACT IMPLANT DATE IS UNKNOWN. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. (B)(6). (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
ADDITIONAL PATIENT INFORMATION: PATIENT HEIGHT REPORTED AS 158 CENTIMETERS. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
A MANUFACTURING INVESTIGATION WAS PERFORMED ON THE RETURNED SUBJECT DEVICE. THE BREAKAGE OF THE LCP (LOCKING 4.5/5 BROAD 12 HOLE PLATE (PART # 426.621, LOT # 9551122) OCCURRED AT THE SIXTH PROXIMAL BORE. ALL RECEIVED EIGHT VARIOUS LOCKING SCREWS 413.3XX ARE INTACT AND UNDAMAGED. THE DIMENSIONS OF THE INVESTIGATED LCP (AS FAR AS MEASURABLE) WERE CHECKED USING A DIGITAL SLIDING CALIPER AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING OF THE PRODUCER AND (B)(4) SPECIFICATIONS. WHEN EXAMINING THE DISTAL FRACTURE SURFACES (PART A AND B) OF THE LCP USING THE SCANNING ELECTRON MICROSCOPE (SEM), THE AREAS OF FRACTURE INITIATION AND THE FRACTURE BEHAVIOR (THE DIRECTION OF FRACTURE PROPAGATION) WERE IDENTIFIED. THE CRACK STARTED AT THE UPPER SIDE OF THE PLATE AND RAN INTO THE MATERIAL. DOCUMENTED FATIGUE CRACKS CLOSE TO THE INITIAL FRACTURE ZONE INDICATE MULTIPLE CRACK INITIATION. AFTER BREAKING, THE TWO FRAGMENTS RUBBED AGAINST EACH OTHER CAUSING STRONG DESTRUCTION OF THE FRACTURE SURFACES (ABRADED AND SHINY AREAS). AT A HIGHER MAGNIFICATION, FATIGUE STRIATIONS WERE OBSERVED AT THE CRACK PROPAGATION ZONES. EACH STRIATION REPRESENTS THE SUCCESSIVE POSITIONS OF AN ADVANCING CRACK FRONT, ORIGINATING FROM CYCLIC LOADS (LOAD AND UNLOAD DURING WALKING). THE PRESENCE OF THESE STRIATIONS IS A CLEAR INDICATION OF A FATIGUE PROCESS. THE FRACTURE SURFACES SHOWED MAINLY STRUCTURED BREAKAGE (CRYSTALLOGRAPHIC ORIENTED FATIGUE FRACTURE). STRUCTURED BREAKAGE IS TYPICAL FOR A FATIGUE FRACTURE IN PURE TITANIUM AND INDICATES MODERATE LOADS. SEM OBSERVATIONS AND FINDINGS SHOWED THAT THE PLATE FAILURE WAS CAUSED BY FATIGUE AND OVERLOAD. THE LCP WAS IMPLANTED BECAUSE OF A LEFT FEMUR FRACTURE AFTER A FALL OF THE PATIENT ON (B)(6)2016. AS FAR AS COULD BE SEEN ON THE X-RAY IMAGES, THE PLATE WAS STABILIZED WITH EIGHT LOCKING SCREWS. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, WE CAN CONCLUDE THAT THE IMPLANT WAS SUBJECTED TO MODERATE DYNAMIC BENDING LOADS (ONE SIDED). CONSTANT ALTERNATING LOAD CYCLES (DURING WALKING) LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE LCP. DUE TO A BONE GAP SITUATION AS SHOWN ON THE POST-OP X-RAY FROM THE FIRST SURGERY THE LCP HAD TO ACT AS A SINGLE STABILIZER. THE PLATE COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD FATIGUE FAILURE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
(B)(6). DATE OF IMPLANT IS SOMETIMES BETWEEN (B)(6) 2016 WHEN THE PATIENT FELL AND (B)(6) 2017 WHEN THE PATIENT WAS DISCHARGED FROM HOSPITAL. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 426.621, LOT# 9551122. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JUN 29, 2015. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
CONCOMITANT DEVICES REPORTED: LOCKING SCREW (PART# 413.340, LOT# 9019825, QUANTITY 1); LOCKING SCREW (PART# 413.334, LOT# 9041677, QUANTITY 1); LOCKING SCREW (PART# 413.334, LOT# 9177565, QUANTITY 1); LOCKING SCREW (PART# 413.338, LOT# 8969330, QUANTITY 1); LOCKING SCREW (PART# 413.338, LOT# 9019829, QUANTITY 1); LOCKING SCREW (PART# 413.336, LOT# L156693, QUANTITY 1); LOCKING SCREW (PART# 413.336, LOT# 9065381, QUANTITY 1); LOCKING SCREW (PART# 413.342, LOT# 3679494, QUANTITY 1).
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A BROKEN LOCKING COMPRESSION PLATE (LCP). THE MATERIAL WAS IMPLANTED IN (B)(6) 2016. PATIENT CLAIMED THAT SHE DID NOT WEIGHT BEAR. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THE PLATE DID NOT BREAK AT AN OCCUPIED SCREW HOLE. THIS REPORT IS FOR ONE (1) 4.5 MM TI BROAD LCP PLATE 12 HOLES/224 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
ON (B)(6) 2016 PATIENT SUFFERED FROM A FALL. IN THE HOSPITAL A X-RAY OF THE LEFT LEG, REVEALED A LEFT FEMUR FRACTURE. THE SURGEON RECOMMENDED AN OPEN REDUCTION AND INTERNAL FIXATION OF THE FEMUR FRACTURE. THE SURGERY WAS PERFORMED AND A TITANIUM PLATE WAS IMPLANTED. THE SURGERY WAS UNEVENTFUL AND THE PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2017. THE INITIAL RECOVERY WENT WELL. SHE DUTIFULLY ATTENDED ALL PHYSIOTHERAPY AND MAINTAINED A HEALTHY LIFESTYLE. SHE WAS GIVEN MEDICAL LEAVE OF 3 MONTHS. IT WAS REPORTED THAT SHE LOST 6KGS IN WEIGHT DURING THAT TIME. HOWEVER, SOMETIME EARLY (B)(6) 2017, THE PATIENT REPORTED THAT HER LEG WAS BECOMING WEAK AND THE PAIN WAS INCREASING. ON (B)(6) 2017, THE PATIENT WAS READMITTED TO HOSPITAL. A X-RAY TAKEN SHOWED THAT THE PLATE HAD BROKEN. THE SAME SURGEON, REMOVED THE PLATE AND SCREWS. HE REPLACED THEM WITH A SHORTER PLATE WITH SAME NUMBER OF SCREWS. TO AID WITH FURTHER RECOVERY, HE ALSO ADDED BONE GRAFTS. THE CORRECTIVE SURGERY WAS SUCCESSFUL. HOWEVER, THE RECOVERY WAS COMPLICATED BY A WOUND INFECTION AT THE INCISION SITE. THIS RESULTED TO AN EXTENDED STAY AT THE HOSPITAL. PATIENT WAS FINALLY DISCHARGED ON (B)(6) 2017. AS OF (B)(6) 2017, PATIENT IS ABLE TO SLOWLY AMBULATE WITH THE AID OF A WALKER. SHE REPORTS THAT SHE HAS MUCH MORE PAIN AND REQUIRES PAINKILLERS. THE PATIENT IS DUTIFULLY DOING PHYSIOTHERAPY AND IS SCHEDULED FOR A REVIEW ON (B)(6) 2017. THE EVENT OF THE BROKEN PLATE IS CAPTURED UNDER (B)(4). THE EVENT OF THE INFECTION IS CAPTURED UNDER (B)(4). CONCOMITANT DEVICE REPORTED: SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236281 | 4.5MM TI BROAD LCP® PLATE 12 HOLES/224MM | PLATE, FIXATION, BONE | HRS | JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. | 9551122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |