MAUDE Adverse Event Report: ZIMMER GMBH NCB PP DIS FEM PLT L18H L355MM; TRAUMA, PLATE.

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: report source united kingdom.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent a revision post implantation due to fatigue failure of distal ncb plate.Attempts have been made and additional information on the reported event is unavailable at this time.
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 following sections were updated: b4, d9, g3, g6, h2, h3, h6, h11 the reported product was returned to the post market surveillance team for examination with one ncb cable button (ref (b)(4)).The device macroscopically exhibits scratches throughout the surface, but mainly on the non-contact facing side.The reported event of implant fracture can be confirmed.The fracture of the plate is located through a screw hole.There are some horizontal scratches/abrasion marks at a nearby screw hole, possibly due to contact with a cerclage wire.The lot number engraved on the device matches the lot number of the reported product on the distal fracture surfaces of the plate, beach marks 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 polished areas and some scratches, most probably due to contact between the parts after the fracture.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Based on the available information, the reported event can be confirmed a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, a3, b3, b4, g3, g6, h2, h3, h6, h11.If any further information is found which would change or alter any conclusions or information, a supplemental 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.
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 following sections were updated: b4, g3, g6, h2, h3, h6, h11.Radiographs in the form of four view of the left femur and two views of the left femur were received and reviewed by a radiologist with the following assessment: four views of the left femur demonstrates a left total hip arthroplasty and left total knee arthroplasty.There is also a lateral side plate and screw fixation device with two cerclage wires.Oblique fracture of the left femoral diaphysis.Two views of the left femur demonstrate a left total knee arthroplasty.Left total hip arthroplasty is also seen.Plate and screw fixation device along the lateral femur with fractured plate at the level of the oblique fracture mid diaphysis.Osteopenia.The outcome of the investigation remains unchanged.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NCB PP DIS FEM PLT L18H L355MM
• Common Device Name: TRAUMA, PLATE.
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• 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: 19557400
• Report Number: 0009613350-2024-00241
• Device Sequence Number: 11945753
• Product Code: HRS
• UDI-Device Identifier: 00889024292918
• UDI-Public: (01)00889024292918(17)321111(10)3140609
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 02/06/2025

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: 0202264118
• Device Lot Number: 3140609
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 10/21/2024; 01/27/2025
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/05/2024; 11/19/2024; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male