MAUDE Adverse Event Report: ZIMMER GMBH NCB, DF PLATE, LEFT, 13 HOLES, LENGTH 324 MM; NCB PLATING SYSTEM

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 10/30/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.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.(b)(4).

Event Description

It was reported that the patient was implanted a ncb, femur plate, left, 13 holes, 324 mm on (b)(6) 2016 on the left side.It was also reported: "the patient fell at home on (b)(6) 2016 due to not following the partial weight bearing." the patient underwent a revision surgery on (b)(6) 2016 due to the breakage of the implant caused by patient's accident.

Manufacturer Narrative

The manufacturer did not receive devices for review.Surgical reports and x-rays have been received for investigation.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).

Event Description

It was reported that the patient was implanted a ncb, femur plate, left, 13 holes, 324 mm on (b)(6) 2016 on the left side.It has now been reported that the plate broke on (b)(6) 2016.The patient underwent a revision surgery on (b)(6) 2016 due to the breakage of the implant caused by patient's accident.Patient's medical history: lack of compliance with dementia, patient can not implement partial exposure; diabetes, cardiac arrhythmia, cardiac pacemaker patient, knee-tep bilateral, chronic heart failure stage 3.

Manufacturer Narrative

Trend analysis: no trend identified.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.- event summary: it was reported that the patient had a ncb femoral plate, implanted on (b)(6) 2016 and revised on (b)(6) 2016 due to a implant breakage.Review of received data - a cd was received with several x-rays and image sequences.On (b)(6) 2008 (1 x-ray full-leg view, right): postoperative image on visible skin clamps.Inconspicuous surface replacement prosthesis, right knee.On (b)(6) 2016 (1x-ray thorax dv, 1 x-ray pelvis, 1 x-ray femur left proximal ap, 1 x-ray femur left knee joint ap, 1 x-ray femur left knee joint lateral): - anterior pacemaker, widened heart sutures, elongated aorta, increased pulmonary vascular lining.- side comparatively small diminished joint space right hip with pelvis on the left, rarefied bone structure proximal femoral on both sides - femoral fracture of the femur on the distal side with a medial flexion wedge, fracture extenders reaching to the femoral plate of the prosthesis, adjoining vascular calcifications femoral and popliteal.On (b)(6) 2016 (ct femur left distal with knee joint): fractures can be seen up to the upper edge of the femur.On (b)(6) 2016 (bv image sequence femur distal with knee joint after attachment of cerclage fixation and subsequent osteosynthesis plating system): laterally attached osteosynthesis plate with 3 cerclage at the level of the spiral fracture, 6 screws placed distal to the lowest cerclage, 4 of these 6 screws with projection behind the femoral plate.The proximal part of the plate is not shown, 4 screws are visible above the proximal cerclage.Correct reposition result.On (b)(6) 2016 (1x-ray femur left with knee joint ap and lateral): fracture on the lateral image visible above the femur.6 screws are placed at the level of the femoral plate.On (b)(6) 2016 (1x-ray femur with visible tibial plateau ap and semi-axial, 1x-ray femur distal with knee and proximal tibia lateral): the femur seems to be rotated, so the plate is on the semi-axial projection placed.The proximal part of the plate is not adjacent.Still correct position of the fracture.On (b)(6) 2016 (1x-ray femur proximal with hip joint ap, 1x-ray femur distal with knee joint ap, 1x-ray femur distal with knee joint on the side): visible plate fracture at the level of a screw hole in the region of the former fracture between the proximal and middle cerclage.On (b)(6) 2016 (1x-ray thorax dv): in comparison to the preliminary view from (b)(6) 2016, widened right atrium.On (b)(6) 2016 (bv image sequence femur distal with knee joint after placement of a cerclage and osteosynthesis plate lateral): repositioned fracture with bony defect at the level of the fracture, cerclage attached distal below the fracture area.Six screws inserted distal and 4 screws proximal.- surgical report dated (b)(6) 2016: diagnosis: periprosthetic femur fracture around the knee prosthesis left.No abnormality could be detected in the surgical report.The fracture was fixed with cerclage wires, a ncb plate and several screws.Surgical report dated (b)(6) 2016: diagnosis: breakage of the ncb plate left on (b)(6) 2016.The plate was implanted on (b)(6) 2016.The report describes that the patient had again a fall whereby the plate was broken through the fifth bore hole of the plate (seen from distal).The broken plate was removed and replaced with a new ncb plate 14 holes.Devices analysis - visual examination: the broken plate was returned for investigation.The sub components have not been returned.The broken plate shows an indication for a fatigue fracture (beach lines) and a final rupture on both broken parts of the plate.The final rupture must be occurred due to acting high forces which must be occurred during the fall of the patient.There are also several scratches on the plate surface visible.Conclusion summary: it was reported that a ncb femoral plate was implanted on (b)(6) 2016 and revised on (b)(6) 2016 due to a plate breakage.Several x-rays and surgical reports were received.The review of the surgical report of revision dated (b)(6) 2016 describes that the patient had again a fall and the plate was broken through the fifth bore hole of the plate (seen from distal).The material analysis of the returned plate indicates that no material defects that could have triggered the fracture could be detected.Based on the given information and the results of the investigation, we could identify a root cause for this issue.The plate was broken due to patient accident.The need for further corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer reference number of this file is (b)(4).

• Brand Name: NCB, DF PLATE, LEFT, 13 HOLES, LENGTH 324 MM
• Type of Device: NCB PLATING SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6131245
• MDR Text Key: 60989434
• Report Number: 0009613350-2016-01385
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 02.02260.113
• Device Lot Number: 2682162
• Other Device ID Number: 00889024297418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 85