MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK P 12/14 NECK; PROSTHESIS, 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	03/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Ref 00-8775-032-02 lot 3072132 biolox head.Ref 00-7713-011-00 lot 65229970 kinectiv stem.Ref 00-6305-50-32 lot 64893930 acetabular liner.Ref 00-6250-65-30 lot j7146602 bone screw.Ref 00-6250-65-20 lot 64714735 bone screw.Ref 00-6202-54-22 lot 64843944 shell.Reported event was confirmed due to the review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed.A revision occurred due to the patient falling backwards.An echo confirmed the fracture.The posterior capsule was torn off the trochanter, which was secured with cables.No complications noted, the head, neck and stem were revised with zimmer products.Device history record (dhr) was reviewed and no discrepancies were found.It was reported that the patient fell.However, as the reason for the fall is unknown, 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 01030.
Event or Problem Description
It was reported the patient underwent a left hip revision approximately 1 month post implantation due to a periprosthetic fracture from a fall.The head, neck, and stem were exchanged with addition of cerclage cables to stabilize the fracture without complications.No additional information.

• Brand Name: MODULAR NECK P 12/14 NECK
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14086228
• Report Number: 0001822565-2022-01029
• Device Sequence Number: 5277145
• Product Code: LPH
• UDI-Device Identifier: 00889024137820
• UDI-Public: (01)00889024137820(17)300720(10)64678797
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K182678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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 Model Number: N/A
• Device Catalogue Number: 00784801300
• Device Lot Number: 64678797
• 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: 03/22/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2020
• 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
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 73 KG