MAUDE Adverse Event Report: ZIMMER GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES,324 MM; INTERNAL ORTHOPEDIC FIXATION SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a revision surgery due to broken implant, approximately four (4) years after implantation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).G2: foreign: germany.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 will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected the plate was returned for investigation together with the screws and the locking caps of note, there are two locking plate cable buttons still mounted on the plate.The plate is fractured into two parts.The non-bone-facing surface of the plate shows some scratches.The bone-facing surface of the plate show some scratches and damages in the area close to the fracture line.The fracture of the plate is located through a screw hole.The fractures surfaces of the plate are damaged and present some scratches and polished area most likely due to relative contact of the two pieces after fracture.Nevertheless, it is possible to see the beach lines that points to a possible fatigue fracture.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history identified additional similar complaints for the reported item and the part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Two ap overviews of the left femur were provided and reviewed by a radiologist.Radiographs show lateral plate and screw fixation with a plate fracture and a comminuted femur fracture with varus angulation at the fracture site.The screws and cerclage wires are intact.Hip and knee arthroplasty alignment is maintained.Bone quality is osteopenic.Based on the analysis of the retrieval, a plate fracture can be confirmed and most likely attributed to fatigue.However, since the cause may be multifactorial, consisting of patient- and procedure-related factors, a single definitive root cause could not be identified.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient had a revision surgery due to broken implant, approximately four (4) months after implantation.Due diligence has been completed for this complaint; to date no additional information has been received.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES,324 MM
• Common Device Name: INTERNAL ORTHOPEDIC FIXATION 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18486689
• Report Number: 0009613350-2024-00016
• Device Sequence Number: 6985140
• Product Code: HRS
• UDI-Device Identifier: 00889024292765
• UDI-Public: (01)00889024292765(17)320225(10)3101445
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: 0202263115
• Device Lot Number: 3101445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown