MAUDE Adverse Event Report: ZIMMER GMBH NCB PP DIS FEM PLT L18H L355MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device for investigation as the patient has not been revised.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is 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.(b)(4).
Event or Problem Description
It was reported that a revision surgery is planned following a plate fracture occurred at home.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H3: the complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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).
Event or Problem Description
It was reported that a patient underwent revision surgery approximately six months post-implantation due to implant fracture.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no additional similar investigated events.Event description: it was reported that the patient had a revision surgery on (b)(6) 2019 due to a ncb pp plate fracture.The implantation was on (b)(6) 2019.Review of received data: assessment of imaging: two views of the left femur demonstrate on image one, a left total hip arthroplasty with cerclage wire surrounding the proximal femur.Lateral side plate and screw fixation device with a cerclage wire or band surrounding the distal femoral component.Just distal to the cerclage band is an apparent incomplete fracture involving the medial cortex of the femur.Image two: complete transverse fracture involving the proximal femoral diaphysis at the location of the medial cortex incomplete fracture on image one with apex lateral angulation of the fracture fragments and associated fracture of the lateral side plate and screw fixation device in this region.Impressions: 1.Incomplete fracture involving the medial cortex of the proximal femoral diaphysis which progresses into a complete fracture on image two with associated fracture of the lateral side plate device.Question 1: can you please provide an assessment of the overall fit and alignment of the implants, as well as bone quality in all x-ray images? on image one, overall fit and alignment of the implants is appropriate.Osteopenia is present.Question 2: can you confirm alleged event in either of the images provided? suggestion of an incomplete fracture involving the proximal femoral diaphysis on image one which extends into a complete fracture with fracture of the lateral side plate and screw device on image two.Question 3: can you identify any contributing factors such as evidence of trauma (ie from a fall) that could lead to the fracture? on image two, there is no obvious evidence of trauma other than the complete fracture.There is osteopenia which could have contributed to the fracture.Device analysis: visual examination: the broken ncb pp plate, 11 ncb screws and 9 ncb locking caps were returned for investigation.The fracture of the plate is located through the middle screw hole of the first three hole pattern (seen 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 and some scratches, most probably due to contact between the parts after the fracture.There are also several scratches visible on the surface of the non-bone-facing side of the plate.On the bone-facing side of the plate, close to the fractured screw hole there are polished indentations visible.It can also be seen that the first and second screw holes (counted from proximal) are damaged (drilling traces visible).Review of product documentation: all involved devices are intended for treatment.The product combination was approved by zimmer biomet dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Raw material certificate reviewed on: 22-jan-2020.Conclusion: it was reported that the patient had a revision surgery on (b)(6) 2019 due to a ncb pp plate fracture.The implantation was on (b)(6) 2019.The plate was in vivo for approximately 7 months.The quality records show that all specified characteristics (material, dimensions, surface, etc.) for the ncb plate have met the specifications valid at the time of production.The visual examination of the plate indicates that no material defects that could have triggered the fracture could be detected.The material analysis shows an indication for a fatigue fracture.There are several factors which may have contributed to the plate breakage.It can be the plate was overstressed during the in vivo time or a wrong patient behaviour can also be the cause for the breakage.In addition, the x-ray review showed that there is osteopenia which could have contributed to the fracture.The investigation results did not identify a non-conformance or a complaint out of box (coob).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).
Event or Problem Description
Please refer to report 0009613350-2019-00593-1.

• Brand Name: NCB PP DIS FEM PLT L18H L355MM
• Common Device Name: NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9165242
• Report Number: 0009613350-2019-00593
• Device Sequence Number: 2811271
• Product Code: HRS
• UDI-Device Identifier: 00889024292918
• UDI-Public: 00889024292918
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 02.02264.118
• Device Lot Number: 2962788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 10/05/2019; 01/22/2020
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 10/25/2019; 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 85