NCB DF PLATE, LEFT, 13 HOLES
Report
- Report Number
- 9613350-2015-00823
- Event Type
- Other
- Date Received
- July 22, 2015
- Date of Event
- May 19, 2015
- Report Date
- June 22, 2015
- Manufacturer
- ZIMMER GMBH
- Product Code
- HRS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- PHYSICIAN
Narratives
THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW AS THE PATIENT HAS NOT BEEN REVISED. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS CPT(B)(4). AN INITIAL REPORT OF THIS CASE HAS ALREADY BEEN SENT BY ZIMMER INC., (B)(4), USA (MFR REPORT NUMBER: 1822565-2015-00960). THE PRODUCT WAS MANUFACTURED BY ZIMMER (B)(4), THEREFORE NO OTHER REPORT WILL BE SENT BY ZIMMER INC., (B)(6). THIS CASE IS NOW HANDLED BY ZIMMER (B)(4).
AFTER SUPPLEMENTAL INFORMATION PROVIDED ON AUGUST 2015: 1 PICTURE WAS PROVIDED, SHOWING ONLY A MAGNIFICATION OF THE REFERENCE/LOT NUMBER OF THE NCB PLATE. TWO X-RAYS WERE SENT FOR REVIEW. THE TWO PICTURES ARE NOT DATED BUT IT IS ASSUMED THAT ONE WAS TAKEN BEFORE THE BREAKAGE (MOST PROBABLY AFTER THE PRIMARY OSTEOSYNTHETIC SURGERY) AND ONE BEFORE THE REVISION; THE SECOND PICTURES SHOWS THE NCB PLATE FROM 2 DIFFERENT ANGLES. THE PLATE BREAKAGE OCCURRED IN THE REGION WERE THE BONE IS FRAGMENTED. THE BONE SHOWS A LONG AND CLEAR DIAGONAL FRACTURE LINE (NO OSTEOSYNTHESIS OCCURRED). POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO SAP DFMEA: - BREAKAGE OF THE PLATE DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE (BINDING SAFETY, STRENGTH STIFFNESS). NOT POSSIBLE: ACCORDING TO THE COMPLAINT SUMMARY AN ADVERSE TREND DUE TO INADEQUATE DESIGN WOULD HAVE BEEN DETECTED. - BREAKAGE OF THE PLATE DUE TO CHEMICAL / GALVANIC/ CREVICE CORROSION OF MATERIAL. POSSIBLE: AS THE PLATE WAS NOT RETURNED, THIS POINT CANNOT BE EXCLUDED. - BREAKAGE OF THE PLATE DUE TO IMPLANTATION OF A DAMAGED IMPLANT. POSSIBLE: IT CAN BE THAT A DAMAGED IMPLANT WAS IMPLANTED. - BREAKAGE OF THE PLATE DUE TO OFF LABEL USE OF IMPLANTS. NOT POSSIBLE: ACCORDING TO X-RAYS PROVIDED AND THE SURGICAL REPORT, THE PARTS SEEMS TO BE CORRECTLY IMPLANTED, THEREFORE AND OFF-LABEL USE CAN BE EXCLUDED. - BREAKAGE OF THE PLATE DUE TO STRENGTH OF THE PLATE IS REDUCED. NOT POSSIBLE: ACCORDING TO THE COMPLAINT SUMMARY AN ADVERSE TREND DUE TO INADEQUATE DESIGN WOULD HAVE BEEN DETECTED. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. ZIMMER CONSIDERS THIS CASE AS CLOSED AGAIN. SHOULD ANY THE DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE ZIMMER WILL RE-EVALUATE THE CASE AND SEND AN AMENDED MEDICAL DEVICE REPORT. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
ADDITIONAL INFORMATION WAS RECEIVED ON 07/23/2015. REFERENCE NUMBERS OF THE DEVICES WERE AVAILABLE AND WERE ADDED TO THE CASE. THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. AS THE PATIENT HAS NOT BEEN REVISED. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS CASE WAS RE-OPENED ON (B)(6) 2015 TO ENTER ADDITIONAL INFORMATION WHICH WAS RECEIVED ON (B)(6) 2015 AND (B)(6) 2015. THE LOT NUMBER WAS NOW PROVIDED AND THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. IT WAS INITIALLY REPORTED THAT THE PATIENT IS EXPERIENCING A CRACKED NCB DF PLATE SYSTEM. ACCORDING TO SUPPLEMENTAL INFORMATION, PATIENT WAS REVISED DUE TO PLATE BREAKAGE AT UNKNOWN DATE. THIS ADDITIONAL INFORMATION DOES NOT CHANGE PREVIOUS MANUFACTURER'S ASSESSMENT OF THE CASE, THE CONCLUSIONS REMAIN THE SAME. ZIMMER CONSIDERS THIS CASE AS CLOSED AGAIN. SHOULD ANY THE DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE ZIMMER WILL RE-EVALUATE THE CASE AND SEND AN AMENDED MEDICAL DEVICE REPORT. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
ADDITIONAL INFORMATION RECEIVED ON AUGUST 13, 2015. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A CRACKED NCB DF PLATE SYSTEM. REVISION SURGERY HAS NOT YET BEEN PERFORMED. THE RUSSIAN SURGICAL REPORT OF IMPLANTATION WAS TRANSLATED IN ENGLISH. THE REPORT DESCRIBED THAT A NCB DF PLATE WAS IMPLANTED WITH SEVERAL SCREWS. THE SURGERY WAS WELL PERFORMED. NO COMPLICATIONS. NO OTHER RELEVANT INFORMATION IN THE REPORT CAN BE FOUND. A CLINICAL SUMMARY OF THE PATIENT WAS PROVIDED. THE REPORT DESCRIBED THAT THE PATIENT HAD A FALL AT HOME ON (B)(6) 2014 AND HAD A LEFT FEMUR FRACTURE. IN ADDITION IT WAS ALSO WRITTEN THAT THE PATIENT HAD DIABETES MELLITUS, CORONARY HEART DISEASE, ATHEROSCLEROTIC CARDIOSCLEROSIS, PERMANENT FORM OF ATRIAL FIBRILLATION, VENTRICULAR EH, CIRCULATORY DEFICIENCY OF 2A STAGE, CONDITION AFTER OPERATIVE TREATMENTS DUE TO COLON AND RECTAL CANCER (1995 AND 1997). A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO PERFORM, AS THE DEVICES WERE NOT AT HAND FOR INVESTIGATION. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO DFMEA: BREAKAGE OF THE PLATE DUE TO CHEMICAL / GALVANIC / CREVICE CORROSION OF MATERIAL. POSSIBLE: AS THE PLATE WAS NOT RETURNED, THIS POINT COULD NOT BE EXCLUDED. BREAKAGE OF THE PLATE DUE TO IMPLANTATION OF A DAMAGED IMPLANT. . POSSIBLE: IT COULD BE THAT A DAMAGED IMPLANT WAS IMPLANTED. BREAKAGE OF THE PLATE DUE TO OFF LABEL USE OF IMPLANTS. POSSIBLE: IT COULD BE THAT AN OFF LABEL WAS PERFORMED AND THEREFORE THE IMPLANT WAS OVER STRESSED, WHICH LED TO THE BREAKAGE. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN UNKNOWN NCB TRAUMA PRODUCT ON (B)(6)2014. CURRENTLY, THE PATIENT IS MONITORED DUE TO BREAKAGE.
IT HAS NOW BEEN REPORTED, THAT THE PATIENT WAS IMPLANTED A NCB DF PLATE, LEFT, 13 HOLES ON THE LEFT SIDE ON (B)(6) 2014. CURRENTLY THE PATIENT IS MONITORED DUE TO BREAKAGE.
IT WAS NOW REPORTED THAT THE PATIENT HAS BEEN REVISED ON AN UNKNOWN DATE AND THAT THE BROKEN PLATE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475513 | NCB DF PLATE, LEFT, 13 HOLES | NCB PLATING SYSTEM | HRS | ZIMMER GMBH | NA | 2709509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Other |