MAUDE Adverse Event Report: ZIMMER GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 12 HOLES, 278 MM; 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	03/19/2019
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 yet, however it is indicated by complainant that it will be returned for investigation.The device history records were reviewed and found to be conforming.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).
Event or Problem Description
It was reported that patient underwent revision surgery due to fracture of the plate.
Additional Manufacturer Narrative
Investigation results were made available.Additional: medical products & therapy dates, follow up type, evaluation codes.Correction: date of report, description of event or problem, concomitant medical products, date received by mfr, type of report, device evaluated by mfr, additional narrative.Concomitant medical products according medical products & therapy dates: item: unknown ncb pp screw trauma, item#: unknown, lot#: unknown.Item: unknown ncb locking caps, item#: unknown, lot#: unknown.Ref:(b)(4) ; lot:2957568 yield:24, delivered:23, scrapped:01, reason for scrapping: push-in.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: medical : revision due to implant fracture event description: it was reported that the patient had been implanted with ncb femoral plate on (b)(6) 2019 and underwent revision on (b)(6) 2019 due to fracture of plate.Review of received data: x-ray review from health care professional (hcp).(b)(6) 2019 - right thigh with knee joint ap-/oblique view: postoperative situation ¿ skin staples visible after periprosthetic plate osteosynthesis lateral by inserted semi constrained knee prosthesis.Possible whitening zone as an indication of the former fracture area.In the area of the fracture two screws outside of the plate.(b)(6) 2019 - right thigh with knee joint ap-/lateral view: breakage of the plate through the most distal located ncb screw hole.Outside the plate recognizable screws in the area of the fracture zone.Compared to the previous x-ray documentation recognizable whitening zone in the area of a former diaphyseal femoral fracture.Dressing material.Devices analysis: visual examination: the broken plate, some screws and locking caps were available for material analysis.A visual examination was performed.The fracture of the plate is located through the sixth screw hole seen from proximal.On the fracture surfaces there are large polished areas, most probably due to contact between the parts after the fracture.One broken piece of the plate shows beach lines.These lines depict the fatigue character of the fracture.The plate shows also several scratches on their outer surface.The screws and locking caps do not show any abnormality or relevant deformation.Based on this visual examination the reported event can be confirmed.Review of product documentation: all involved devices are intended for treatment.The product combination was approved by zimmer biomet.Surgical technique: in the appropriate surgical technique is described that the prosthesis length as well as the fracture location should determine the plate length, with the length of the patient¿s bone as a secondary guide.The distal square hole of the provisional indicates the end of the periprosthetic zone.In the present case the fracture zone ends proximally of the distal square hole at the level of the most distal located ncb screw.Conclusion summary: it was reported that the patient had been implanted with ncb pp plate on (b)(6) 2019 and underwent a revision surgery on (b)(6) 2019 due to a fracture of the plate.In the appropriate surgical technique is described that the prosthesis length as well as the fracture location should determine the plate length, with the length of the patient¿s bone as a secondary guide.The distal square hole of the provisional indicates the end of the periprosthetic zone.In the present case the fracture zone ends proximally of the distal square hole at the level of the most distal located ncb screw.The visual examination of the plate indicates that no material defects that could have triggered the fracture could be detected.It cannot be determined if the delayed fracture healing may have contributed to the implant breakage.The investigation results did not identify a non-conformance or a complaint out of box (coob).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
Investigation results are now available.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 12 HOLES, 278 MM
• 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: 8513487
• Report Number: 0009613350-2019-00221
• Device Sequence Number: 19532507
• Product Code: HRS
• UDI-Device Identifier: 00889024297562
• UDI-Public: 00889024297562
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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: 02.03264.012
• Device Lot Number: 2957568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 65