MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 9 HOLES, 245 MM; PLATE, FIXATION, BONE

Model Number	02.03263.109
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	03/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery due to implant fracture.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).D10: item#: unknown, lot#: unknown, item name: unknown screws this follow-up report is being submitted to relay additional information and correction.The following sections were updated: a2, a3, b4, b5, b7, d6, d10, g3, g6, h2, h10 investigation of this incident is currently ongoing with the received additional information.Once the investigation is updated, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial left total knee arthroplasty on unknown date with unknown components.Subsequently, an open reduction and internal fixation (orif) was performed as a result of a fall and implanted with zb plate and unknown screws.A 2nd orif was performed 18 months later due to implant fracture.Plate and screws were exchanged with unknown product and bone matrix putty.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: a2, b4, b5, d9, g3, g6, h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of manufacturing records cannot be performed without product identification.The device is used for treatment.Medical records were provided and reviewed by a health care professional.The patient underwent an initial left tha, however no medical records or further information for this procedure were provided, the patient underwent revision surgery due to a periprosthetic fracture after a fall and the zb was implanted.Subsequently, the patient underwent a second open reduction internal fixation due to a plate fracture.A total of 4 undated radiographs were provided and reviewed by a radiologist.Two radiographs present no bone fracture or hardware failure, therefore it is not possible to determine in which time points were taken: these images do not provide any additional information that contributes to the investigation.Two radiographs show a fracture of the plate, therefore it is possible to assume that these images were taken before revision surgery.All images demonstrate callus development with cortical thickening in the medial femoral diaphysis.With the available information a definitive root cause cannot be established.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.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 9 HOLES, 245 MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER 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: 16760135
• Report Number: 0009613350-2023-00174
• Device Sequence Number: 11521633
• Product Code: HRS
• UDI-Device Identifier: 00889024297500
• UDI-Public: (01)00889024297500
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2023

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: 02.03263.109
• Device Catalogue Number: 02.03263.109
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 04/27/2023; 06/23/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/23/2023; 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female