MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN LH 130 DEG 11MM X 400MM; ROD, FIXATION, INTRAMEDULLARY, AND ACCESSORIES/TRAUMA

Catalog Number	814611400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Swelling/ Edema (4577)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 814501085, hfn a/r screw 85mm; lot#: zn1121285g.Item#: 814550042, cortical bone scr 5.0mm x 42mm; lot#: m36773c.Item#: 814550042, cortical bone scr 5.0mm x 42mm; lot#: m35214twa.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial orif with cephalomedullary nail left subtrochanteric hip fracture approximately ten (10) and a half months ago due.Subsequently, the patient underwent a revision surgery three (3) months later due to nonunion and a fractured implant that caused pain and swelling.
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.H6: component codes: mechanical: im nail.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: relevant findings: (b)(6) 2024; er visit.¿ left hip pain and swelling.¿ xray show ¿what appears to be failure of im nail with nonunion and bending of the prosthesis¿.(b)(6) 2024; removal of orthopedic hardware.¿ proximal aspect of the nail and screws removed without difficulty.¿ distal aspect of the nail was broken and explanted.¿ fluoroscopy confirmed removal of broken hardware.¿ nail and screws implanted.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: AFFIXUS HFN LH 130 DEG 11MM X 400MM
• 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: 21150397
• Report Number: 0001825034-2025-00143
• Device Sequence Number: 9135065
• Product Code: HSB
• UDI-Device Identifier: 00887868039836
• UDI-Public: (01)00887868039836(17)270512(10)926300
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: Health Professional
• Device Catalogue Number: 814611400
• Device Lot Number: 926300
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2017
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male