MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN RH 125 DEG 11MM X 360MM; TRAUMA, IMPLANT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: item# 814550040; lot# m18650a; cortical bone scr 5.0mm x 40mm; item# 814550040; lot# m15109a; cortical bone scr 5.0mm x 40mm; item# 814510110; lot# vj1111310b; hfn lag screw 10.5mm x 110mm; item# 814501095; lot# uk1111295c; hfn a/r screw 95mm.Foreign: event occurred in (b)(6).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.Product not returned.
Event or Problem Description
It was reported that the patient underwent an initial procedure on an unknown date.Subsequently, the patient was revised due to fracture of the affixus nail.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall fit and alignment appears normal, although there subtle varus alignment of the proximal femur related to the periprosthetic fracture.No confirmed signs of loosening, wear, or radiolucency.No confirmed contributing factors; however both the proximally placed screws are not centrally positioned within the femoral head.It is uncertain if this could be a contributing factor, but such a possibility is not excluded.Mmi noted bone fracture, however, with only one x-ray and cerclage wires already present, it remains unknown whether this was a new fracture or a malunion of the previous fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information 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: HFN RH 125 DEG 11MM X 360MM
• Common Device Name: TRAUMA, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11265856
• Report Number: 0001825034-2021-00134
• Device Sequence Number: 1164746
• Product Code: HSB
• UDI-Device Identifier: 00887868038143
• UDI-Public: (01)00887868038143(17)290211(10)633330
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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 Model Number: N/A
• Device Catalogue Number: 814311360
• Device Lot Number: 633330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention