MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN LH 125 DEG 9MM X 440MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES/TRAUMA

Catalog Number	814409440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip surgery on and unknown date.Subsequently, the patient was revised approximately two (2) months ago due to the implant fracturing.There was no report of a foreign body being retained by the patient.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 814510095, hfn lag screw 10.5mm x 95mm; lot#: xp1112295.Item#: 814501090, hfn a/r screw 90mm; lot#: wg1112290i.Item#: 814550042, cortical bone scr 5.0mm x 42mm; lot#: unknown.H3: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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 corrected information.Visual examination of the returned product identified the nail was received in 6 pieces.Scratches noticed on the nail.Part is verified to be broken.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single ap view of the left hip demonstrates a fractured left femoral intramedullary rod at the level of a lag screw.Anti-rotation screw also seen.Transverse fracture involving the proximal femoral diaphysis and lesser trochanter also seen.Sizing of the hardware is appropriate.No signs of loosening, wear, radiolucency, or any other contributing factor such as malalignment that would cause issues with any of the components on the x-ray.A definitive root cause cannot 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: HFN LH 125 DEG 9MM X 440MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES/TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17861580
• Report Number: 0001825034-2023-02295
• Device Sequence Number: 5909351
• Product Code: HSB
• UDI-Device Identifier: 00887868038419
• UDI-Public: (01)00887868038419(17)280222(10)5639205
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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: Health Professional
• Device Catalogue Number: 814409440
• Device Lot Number: 5639205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2018
• 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: 34 YR
• Patient Sex: Male