MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM CEMENTLESS COLLARLESS STANDARD OFFSET 12/14 TAPER SIZE 6; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).010000665.Pps ltd acet shell 56f lot number: 7274548.30123606.36mm i.D.Size f high wall liner lot number: 65588037.802203603.Femoral head 12/14 taper 36 mm diameter +3.5 mm neck length lot number 3120484.Foreign: denmark.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 00359.0001822565 - 2023 - 00360.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.Device remains implanted.
Event or Problem Description
It was reported that the patient had an intra-operatively induced fracture of the femur that likely occurred during implantation of the femoral stem.The anterior calcar fracture was discovered intra-operatively and treated right away with a cerclage wire.The distal periprosthetic femoral fracture (fracture number 2) was discovered on post-operative x-ray, which was taken on the day of surgery.The distal periprosthetic femoral fracture was treated conservatively (no weight bearing for 6 weeks) there were no contributing factors.No additional information was available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h6 : proposed component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.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.
Event or Problem Description
There is no update to the prior event description provided.

• Brand Name: FEMORAL STEM CEMENTLESS COLLARLESS STANDARD OFFSET 12/14 TAPER SIZE 6
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16351957
• Report Number: 0001822565-2023-00361
• Device Sequence Number: 17709815
• Product Code: LZO
• UDI-Device Identifier: 00889024508668
• UDI-Public: (01)00889024508668(17)260623(10)3069376
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2026
• Device Model Number: N/A
• Device Catalogue Number: 574101060
• Device Lot Number: 3069376
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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: Unknown
• 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: Other; Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose