MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 18 HOLES, 355 MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that: the patient underwent a revision of the left hip due to implant fracture, approximately three (3) months post-op.Due diligence is in progress for this complaint; to date, no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Report source ¿ foreign ¿ (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.D10 - medical deices: ncb clamp-screw item# 02.02150.300 lot# unknown.Ncb screw 5.0 l = 38 item# 02.02150.038 lot# unknown.Ncb screw 5.0 l = 48 item# 02.02150.048 lot# unknown.Ncb screw 5.0 l = 44 item# 02.02150.044 lot# unknown.Product was not returned but a picture was provided.Review of the picture can confirm the reported event; however, no further product evaluation can be done.A review of the device manufacturing records confirmed no abnormalities or deviations.Device used for treatment.Medical records were provided and reviewed.Patient was implanted with a plate and went through revision surgery due to fracture.An x-ray showing an overview of the left femur before revision surgery was provided and reviewed from and health care professional.It can be confirmed that the plate fractured.The visualized screws are intact.There is cortical disruption of the femur at the level of the plate fracture.There is mild displacement at the fracture site and varus angulation of the femur.Osteopenic bone quality and regional heterotopic ossification is noted.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.
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 information.The product was returned for investigation.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 heavily damaged and present some scratches and polished area most likely due to relative contact of the two pieces after fracture.The new available information does not change the outcome of the investigation.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
No further event information available at the time of this report.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 18 HOLES, 355 MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 16120753
• Report Number: 0009613350-2023-00010
• Device Sequence Number: 15592899
• Product Code: HRS
• UDI-Device Identifier: 00889024292918
• UDI-Public: (01)00889024292918(17)320524(10)3113192
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 08/17/2023

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: N/A
• Device Catalogue Number: 02.02264.118
• Device Lot Number: 3113192
• 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: 12/22/2022
• Supplement Date Received by Manufacturer: 03/15/2023; 08/16/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/21/2023; 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 100 KG