NCB, FEMUR PLATE, RIGHT, 13 HOLES, 324 MM
Report
- Report Number
- 0009613350-2018-01060
- Event Type
- Injury
- Date Received
- October 4, 2018
- Date of Event
- September 14, 2018
- Report Date
- January 23, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- HRS
- PMA / PMN Number
- PK042695
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
DHR-REVIEW: REF:(B)(4); LOT:2931605. YIELD: 25. DELIVERED: 25. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: PLATE BREAKAGE. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH NCB PLATE ON (B)(6) 2018 AND WAS REVISED ON (B)(6) 2018 DUE TO BREAKAGE. REVIEW OF RECEIVED DATA: SEVERAL X-RAY PICTURES WERE RECEIVED AND REVIEWED BY AN INDEPENDENT HEALTHCARE PROFESSIONAL. SURGICAL REPORT IMPLANTATION ON (B)(6) 2018: SURGERY REPORT DR. (B)(6) ON THE PERFORMED OPERATION ON (B)(6) 2018. OPERATION DIAGNOSIS: FRACTURE OF THE FEMUR STEM. OSTEOPOROSIS. TOTAL KNEE ARTHROPLASTY. INDICATION: PERIPROSTHETIC FEMORAL STEM FRACTURE AFTER IMPLANTATION OF A REVISION TOTAL KNEE ARTHROPLASTY WITH INSERTING OF A CABLE CERCLAGE. THERAPY: REMOVAL OF THE CERCLAGE WIRE, OPEN REDUCTION AND OSTEOSYNTHESIS BY AN ANGEL STABLE 14-LOCH-NCB-PLATE ON (B)(6) 2018. THE FRACTURE IS ABOUT 3 CM ABOVE THE FEMORAL STEM OF TOTAL KNEE ARTHROPLASTY. AFTER PREPARATION OF THE FRACTURE AREAL A SIGNIFICANT DISLOCATED TRANSVERSE FRACTURE IS VISIBLE, ABOUT 3 CM ABOVE THE FEMORAL STEM OF THE KNEE ARTHROPLASTY. REMOVING OF THE CERCLAGE WIRE, EXCISION AND SMEAR COLLECTION FROM THE AREA OF THE BREAKAGE, NO MACROSCOPIC EVIDENCE OF INFECTION. BECAUSE OF THE SPONGIOSA DEFECT IN THE AREA OF THE FRACTURE AREA, FIRST IMPLANTATION OF A 2 X 2 X 1 CM ENDOBONE BLOCK. THEREAFTER EXERCISE-STABLE FIXATION BY MEANS OF AN ANGULARLY STABLE NCB PLATE (TITANIUM) AND COMPRESSION. THE RESPECTIVE SCREWS ARE PLACED AROUND THE PROSTHETIC PORTIONS FOR SUFFICIENT SUPPORT UNDER C-ARM CONTROL. THE FRACTURE IS CARED EXERCISE STABLE. THE FRACTURE IS EXERCISE-STABLE. INTRAOPERATIVELY MAKING OF PRINT IMAGES FOR DOCUMENTATION. SURGICAL REPORT REVISION ON (B)(6) 2018: SURGERY REPORT DR. (B)(6). INDICATION: BREAKAGE OF THE PLATE AFTER PERFORMING OF A NCB-PLATE DUE TO A PERIPROSTHETIC FRACTURE OF THE FEMUR STEM. THE PLATE WAS BROKEN. AFTER FREE PREPARATION OF THE PLATE BASE MACROSCOPIC NO EVIDENCE OF AN INFECTION. AT THE LEVEL OF THE FORMER FRACTURE A COMPLETE BREAKAGE OF NCB-PLATE CAN BE SEEN. IN THE AREA OF THE FORMER FRACTURE, A RANGE OF ABOUT 50% WITH VIRTUALLY BONY CONSOLIDATION IS RECOGNIZABLE, HOWEVER, IN THE MEANTIME FRESHLY BROKEN. FOR THE OTHER 50% THE TYPICAL IMAGE OF A NON-UNION IS RECOGNIZABLE ¿ EXCISION OF A CORRESPONDING SAMPLE. RESECTION OF THE NON-UNION AND REVITALIZATION OF THE FRACTURE ENDS. INSERTING OF A NEW NCB PLATING SYSTEM AND AO-PLATE. DEVICES ANALYSIS: VISUAL EXAMINATION: THE BROKEN PLATE WAS AVAILABLE FOR MATERIAL ANALYSIS. THE SUB COMPONENTS (SCREWS) HAVE NOT BEEN RETURNED. A VISUAL EXAMINATION WAS PERFORMED. THE FRACTURE OF THE PLATE IS LOCATED THROUGH THE MIDDLE OF THE SEVENTH SCREW HOLE (COUNTED FROM PROXIMAL). ON THE FRACTURE SURFACES, BEACH LINES ARE VISIBLE WHICH POINT TO A FATIGUE FRACTURE. THE FRACTURE ORIGINS ARE LOCATED AT THE BEGINNING OF THE CHAMFER ON THE NON-BONE-FACING SIDE. ON THE FRACTURE SURFACES THERE ARE SMALL POLISHED AREAS, MOST PROBABLY DUE TO CONTACT BETWEEN THE PARTS AFTER THE FRACTURE. THE SEVENTH SCREW HOLE OF THE PLATE SHOWS DRILL MARKS BOTH ON THE BONE-FACING SIDE AND NON-BONE FACING SIDE. THE THREAD OF THE SEVENTH SCREW HOLE, ON THE DISTAL FRACTURE SURFACE SIDE, SHOWS SOME AREAS WITH WEAR AND DEFORMATION, PROBABLY DUE TO THE CONTACT WITH THE SCREW AFTER THE FRACTURE. SEVERAL OTHER SCREW HOLES OF THE PLATE SHOW AS WELL DRILL MARKS. ON THE NON-BONE FACING SIDE OF THE PLATE SEVERAL SPOT-LIKE DISCOLORATIONS CAN BE SEEN. THESE CAN PROBABLY BE ATTRIBUTED TO THE USE OF AN ELECTROSURGICAL INSTRUMENT (CAUTER) DURING SURGERY. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: BREAKAGE OF IMPLANT DUE TO MOVEMENT BETWEEN IMPLANTS LEADS TO NOTCHING / FRETTING. NOT POSSIBLE, AS THE PRODUCT INVESTIGATION DID NOT SHOW ANY SIGNS OF NOTCHING. BREAKAGE OF IMPLANT DUE TO INADEQUATE IMPLANT DESIGN & MATERIAL (FATIQUE STRENGTH - LIFETIME OF THE DEVICE). NOT POSSIBLE, AS A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. BREAKAGE OF IMPLANT DUE TO CHEMICAL / GALVANIC / CREVICE CORROSION OF MATERIAL. NOT POSSIBLE, AS THE PRODUCT INVESTIGATION DID NOT SHOW ANY SIGNS OF CORROSION. BREAKAGE OF IMPLANT DUE TO WRONG INTERPRETATION OF IN SITU DEVICE POSITION AND/OR DIMENSION. NOT POSSIBLE, AS THE X-RAYS DID NOT SHOW ANY DEVIATION OF THE DEVICE POSITION. BREAKAGE OF IMPLANT DUE TO WRONG INTERPRETATION OF X-RAY TEMPLATE FOR DIMENSIONS. NOT POSSIBLE, AS THE X-RAYS DID NOT SHOW ANY DEVIATION OF THE DEVICE DIMENSIONS. BREAKAGE OF IMPLANT DUE TO USER PERFORM INADEQUATE FORCE TO THE PLATE. POSSIBLE, IT CAN BE THE CASE THAT THE USER PERFORMED INADEQUATE FORCE DURING THE INITIAL SURGERY. BREAKAGE OF IMPLANT DUE TO USER DEFINE INCORRECT PLACEMENT OF THE SPACERS AND PLATE. NOT POSSIBLE, AS NO SPACERS WERE USED IN THE SURGERY. BREAKAGE OF THE IMPLANT DUE TO USER PERFORMS INADEQUATE FORCES TO THE PLATE. POSSIBLE, IT CAN BE THE CASE THAT THE USER PERFORMED INADEQUATE FORCE DURING THE INITIAL SURGERY. BREAKAGE OF THE IMPLANT DUE TO USER PERFORM IMPROPER HANDLING OF THE PLATE DURING INSERTION. POSSIBLE, IT CAN BE THE CASE THAT THE USER PERFORMED IMPROPER HANDLING OF THE PLATE. BREAKAGE OF THE IMPLANT DUE TO USER READ/INTERPRETS WRONG SCREW DEPTH. NOT POSSIBLE, AS NO ABNORMALITY WAS DETECTED DURING THE X-RAY REVIEW BY DR. (B)(6). BREAKAGE OF THE IMPLANT DUE TO USER READ/INTERPRETS WRONG SCREW DEPTH. NOT POSSIBLE, AS NO ABNORMALITY WAS DETECTED DURING THE X-RAY REVIEW BY DR. (B)(6). BREAKAGE OF THE IMPLANT DUE TO PATIENT DO NOT FOLLOW THE POSTOPERATIVE PROTOCOL. POSSIBLE, IT CAN BE THE CASE THAT THE PATIENT DID NOT FOLLOW THE POSTOPERATIVE PROTOCOL. BREAKAGE OF THE IMPLANT DUE TO PATIENT DO NOT FOLLOW THE POSTOPERATIVE PROTOCOL. POSSIBLE, IT CAN BE THE CASE THAT THE PATIENT DID NOT FOLLOW THE POSTOPERATIVE PROTOCOL. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH NCB PLATE ON (B)(6) 2018 AND WAS REVISED ON (B)(6) 2018 DUE TO BREAKAGE. THE PLATE WAS IN VIVO FOR APPROX. 6 MONTHS. THE REVIEW OF THE X-RAYS CONFIRMS THE BREAKAGE OF THE NCB PLATE. THE VISUAL EXAMINATION OF THE PLATE INDICATES THAT NO MATERIAL DEFECTS THAT COULD HAVE TRIGGERED THE FRACTURE COULD BE DETECTED. THE PRODUCT ANALYSIS SHOWS AN INDICATION FOR A FATIGUE FRACTURE. THERE ARE SEVERAL FACTORS WHICH MAY HAVE CONTRIBUTED TO THE PLATE BREAKAGE. IT CAN BE THAT THE PLATE WAS OVER STRESSED DURING THE IN VIVO TIME OR A WRONG PATIENT BEHAVIOR CAN ALSO BE THE CAUSE FOR THE BREAKAGE. HOWEVER, BASED ON THE AVAILABLE INFORMATION AND PERFORMED INVESTIGATION, AN EXACT ROOT CAUSE FOR THE PLATE BREAKAGE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF INITIAL MEDWATCH. NEW INFORMATION RECEIVED: - IMPLANT DATE: (B)(6), 2018 - EXPLANT DATE: (B)(6), 2018 - REVISION REASON: PAIN, PLATE BREAKAGE ABOVE THE FORMER FRACTURE AREA - OP-DIAGNOSIS: IMPLANT FRACTURE; NON-UNION OF THE FRACTURED PELVIC / FEMORAL AREA - PATIENT SUFFERS FROM OSTEOPOROSIS, SEVERE ANEMIA AND AN AUTOIMMUNE DISEASE KNOWN AS SICCA SYNDROME. - NO INDICATION OF INFECTION WAS FOUND - X-RAYS HAVE BEEN RECEIVED - SURGICAL REPORT: DURING REVISION IT WAS FOUND THAT IN THE AREA OF THE FORMER FRACTURE THE PLATE IS COMPLETELY BROKEN. FURTHERMORE IN THIS SAME AREA IT IS NOTICED THAT 50% OF THE PREVIOUSLY HEALED BONE IS NEWLY FRACTURED AGAIN; ANOTHER 50% OF THIS AREA SHOWS TYPICAL SIGNS OF PSEUDOARTHOSIS. THE DEVICE RETURNED FOR INVESTIGATION. AN INVESTIGATION OF THE CASE WAS STARTED. THE PROCESS OF GAINING NECESSARY INFORMATION IS STILL ONGOING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
NO NEW INFORMATION.
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN AND NCB PLATE BREAKAGE ON THE RIGHT SIDE.
(B)(4). AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO NCB PLATE BREAKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 774262 | NCB, FEMUR PLATE, RIGHT, 13 HOLES, 324 MM | NCB PLATING SYSTEM | HRS | ZIMMER GMBH | N/A | 2931605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| R |