NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 9 HOLES, 238 MM
Report
- Report Number
- 0009613350-2018-00788
- Event Type
- Injury
- Date Received
- August 8, 2018
- Report Date
- January 16, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- HRS
- PMA / PMN Number
- PK100111
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
AS THE CASE AT HAND IS A LEGAL CLAIM IT IS NOT SUSPECTED THAT THE DEVICES OR ADDITIONAL INFORMATION ARE BEING SUBMITTED FOR REVIEW. ZIMMER GMBH WINTERTHUR LEGAL DEPARTMENT HAVE ALREADY PASSED ALL INFORMATION THAT WAS RECEIVED FROM THE LAWYER, TO OUR COMPLAINT HANDLING DEPARTMENT. BY EXPERIENCE ZIMMER GMBH NEVER GETS MORE INFORMATION EXCEPT FOR THE ONE THAT HAS BEEN ALREADY COVERED IN THE FINAL REPORT. PATIENTS¿ ADVOCATES ONLY PROVIDE TO ZIMMER GMBH AS MUCH INFORMATION AS THEY ARE WILLING TO SHARE TO PROTECT THE RIGHTS OF THEIR CLIENTS. ALL INFORMATION WHICH HAS BEEN PROVIDED FOR THIS PARTICULAR CASE IS ALREADY COVERED IN THE FINAL REPORT. NEVERTHELESS, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE TO US, A FOLLOW UP REPORT WILL BE SUBMITTED. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO BE PERFORMED, AS THE DEVICE(S) WERE NOT AT HAND FOR INVESTIGATION. HOWEVER, BASED ON THE AVAILABLE INFORMATION THE INVESTIGATION IS CONDUCTED WITH OUTCOME AS FOLLOWS. DHR REVIEW: 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: FRACTURE / PATIENT BONE FRACTURE. REVIEW OF EVENT DESCRIPTION: IT HAS BEEN REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT INITIAL SURGERY TOOK PLACE ON (B)(6) 2018 AT (B)(6) HOSPITAL SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY ON AN UNKNOWN DATE AT (B)(6) HOSPITAL IN (B)(6) DUE TO A 9 PIN PLATE SNAPPING CAUSING A FRACTURE TO PATIENTS LEG. THE PRODUCT HAS NOT BEEN RECEIVED FOR INVESTIGATION. ONLY THE PATIENTS BIRTH DATE IS KNOWN, OTHERWISE NO PATIENT INFORMATION IS GIVEN. REVIEW OF RECEIVED DATA: A SURGICAL NOTE WAS RECEIVED WITH COPIES OF THE IMPLANT STICKERS FROM THE INITIAL SURGERY: RIGHT DISTAL FEMUR, OPEN REDUCTION, FIXATION OF PERIPROSTHETIC FRACTURE. REDUCED AND HELD WITH 9 HOLE PLATE, 6 PROXIMAL UNLOCKED SCREWS AND 7 DISTAL LOCKED SCREWS. POST-OPERATIVE NON-WEIGHT BEARING FOR AT LEAST 8 WEEKS. ON (B)(6) 2018 IT WAS REPORTED THAT BLOOD PRESSURE WAS SLIGHTLY LOW IN THE MORNING. BLOOD TEST WAS PERFORMED. NO CONCERN DURING THE NEXT NIGHT. OTHERWISE, NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE AVAILABLE INFORMATION, THE PRODUCT LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION: THE REPORTED PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET ACCORDING TO SURGICAL TECHNIQUE. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: BREAKAGE OF IMPLANT DUE TO MOVEMENT BETWEEN IMPLANTS LEADS TO NOTCHING / FRETTING. POSSIBLE AS NEITHER X-RAYS NOR THE DEVICE WERE RECEIVED THIS CAUSE CANNOT BE EXCLUDED. BREAKAGE OF IMPLANT DUE TO INADEQUATE IMPLANT DESIGN & MATERIAL (FATIQUE STRENGTH - LIFETIME OF THE DEVICE) NOT POSSIBLE AS A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. BREAKAGE OF IMPLANT DUE TO CHEMICAL / GALVANIC / CREVICE CORROSION OF MATERIAL. POSSIBLE AS NEITHER X-RAYS NOR THE DEVICE WERE RECEIVED THIS CAUSE CANNOT BE EXCLUDED. BREAKAGE OF IMPLANT DUE TO IMPLANT WILL BE IMPLANTED AGAINST CONTRAINDICATION POSSIBLE, AS NO MEDICAL DOCUMENTATION WAS RECEIVED THIS CAUSE CANNOT BE EXCLUDED. BREAKAGE OF IMPLANT DUE TO WRONG INTERPRETATION OF IN SITU DEVICE POSITION AND/OR DIMENSION POSSIBLE, AS NO X-RAYS WERE RECEIVED. BREAKAGE OF THE IMPLANT DUE TO WRONG INTERPRETATION OF X-RAY TEMPLATE FOR DIMENSIONS POSSIBLE, AS NO X-RAYS WERE RECEIVED. BREAKAGE OF IMPLANT DUE TO TOO MANY BENDING CYCLES AT THE SAME SPOT OR USE OF NCB SCREW HOLES WHICH HAVE BEEN BENT POSSIBLE, AS NO FURTHER SPECIFIC INFORMATION WAS RECEIVED. BREAKAGE OF IMPLANT DUE TO USER DEFINE INCORRECT PLACEMENT OF THE SPACERS AND PLATE POSSIBLE, IT IS UNKNOWN IF ALSO SPACERS WERE USED. BREAKAGE OF IMPLANT DUE TO USER PERFORM IMPROPER HANDLING OF THE PLATE DURING INSERTION POSSIBLE, AS NO MEDICAL DOCUMENT SUCH AS A SURGICAL REPORT WAS RECEIVED. BREAKAGE OF THE IMPLANT DUE TO TOO MANY BENDING CYCLES AT THE SAME SPOT OR USE OF NCB SCREW HOLES WHICH HAVE BEEN BENT. POSSIBLE AS NEITHER X-RAYS NOR THE DEVICE WERE RECEIVED THIS CAUSE CANNOT BE EXCLUDED. BREAKAGE OF IMPLANT DUE TO WRONG/ INCOMPLETE INFORMATION ABOUT LIMITATION AND POSTOPERATIVE RESTRICTION POSSIBLE, NO SPECIFIC INFORMATION ABOUT POST-OPERATIVE FOLLOW UP WAS RECEIVED. BREAKAGE OF IMPLANT DUE TO PATIENT DO NOT FOLLOW THE POSTOPERATIVE PROTOCOL POSSIBLE, NO SPECIFIC INFORMATION ABOUT POST-OPERATIVE FOLLOW UP WAS RECEIVED. AS THE EVENT IS INSUFFICIENTLY DESCRIBED ADDITIONAL RISK LINES MAY APPLY. ALL POSSIBLE RISKS RELATED TO THE NCB SUBJECT TO THIS COMPLAINT ARE LISTED IN RMW. CONCLUSION SUMMARY: IT HAS BEEN REPORTED THAT THE PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2018 AT (B)(6) HOSPITAL SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY ON AN UNKNOWN DATE AT (B)(6) HOSPITAL IN (B)(6) DUE TO A 9 PIN PLATE SNAPPING CAUSING A FRACTURE TO PATIENTS LEG. THE PRODUCT HAS NOT BEEN RECEIVED FOR INVESTIGATION. EXCEPT OF THE PATIENTS BIRTH DATE NO OTHER PATIENT INFORMATION IS GIVEN. A SURGICAL NOTE WAS RECEIVED CONTAINING A COPY OF THE IMPLANT STICKERS USED DURING THE INITIAL SURGERY. OTHERWISE, NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE 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).
NO EVENT UPDATE.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: NCB, CORTICAL SCREW, SELF-TAPPING, 4.0, 36 MM ITEM#: 0202155036 LOT#: 2865927; NCB, CORTICAL SCREW, 5.0 MM, 38 MM ITEM#: 0202150038 LOT#: 2880327; NCB, CORTICAL SCREW, 5.0 MM, 65 MM ITEM#: 0202150065 LOT#: 2847984; NCB, CORTICAL SCREW, 5.0 MM, 46 MM ITEM#: 0202150046 LOT#: 2856000; NCB, CORTICAL SCREW, 5.0 MM, 55 MM ITEM#: 0202150055 LOT#: 2847983; NCB, CORTICAL SCREW, 5.0 MM, 60 MM ITEM#: 0202150060 LOT#: 2849754; NCB, CORTICAL SCREW, 5.0 MM, 24 MM ITEM#: 0202150024 LOT#: 2843301; NCB, CORTICAL SCREW, 5.0 MM, 40 MM ITEM#: 0202150040 LOT#: 2906778; NCB, LOCKING CAP ITEM#: 0202150300 LOT#: 4501916446; NCB, LOCKING CAP ITEM#: 0202150300 LOT#: 4501916440. CONCOMITANT MEDICAL PRODUCTS: DUE TO FACT THAT THIS IS A LEGAL CLAIM, OUR LEGAL DEPARTMENT HAS BEEN PROVIDED WITH THE AVAILABLE FACTS FROM THE CUSTOMER. ZIMMER (B)(4) LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. AN E-MAIL REQUESTING ADDITIONAL INFORMATION WAS SENT ON JULY 13, 2018 TO THE APPROPRIATE REPRESENTATIVES. 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).
A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 9 HOLES, 238 MM ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT WENT TO REVISION SURGERY DUE TO FRACTURE OF THE PLATE ON AN UNKNOWN DATE. IT WAS ALSO REPORTED THAT THE IMPLANT FRACTURE CAUSED PATIENTS BONE FRACTURE. FURTHER INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 606972 | NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 9 HOLES, 238 MM | NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM | HRS | ZIMMER GMBH | N/A | 2858608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |