MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KINECTIV MODULAR NECK P 12/14 NECK TAPER USE WITH +0 HEADS ONLY; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hematoma (1884); Failure of Implant (1924)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 00620206022 lot# 63835146 shell porous with cluster holes 60 mm.Cat# 00630506040 lot# 66229505 liner standard 3.5 mm offset 40 mm i.D.For use with 60 mm o.D.Shell.Cat# 00625006530 lot# j7593906 bone screw selftapping 6.5 mm dia.30 mm length.Cat# 00625006530 lot# j7618988 bone screw selftapping 6.5 mm dia.30 mm length.Cat# 110005096 lot# 0002551062 juggerknot 2.9 w/ tapered ndls.Cat# 110005096 lot# 0002548224 juggerknot 2.9 w/ tapered ndls.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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent an initial right tha.The patient experienced a fall and was revised as it resulted in a periprosthetic fracture.During the revision, the stem was noted to be loose.A definitive root cause cannot be determined for the loosening and fracture.It was reported the patient fell, however the reason for the fall is unknown.No problem was found with the device in relation to the hematoma after review by a hcp.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
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 3 months later due to periprosthetic fracture following a fall.During the revision 5 cerclage wires were used to reduce and stabilize the fracture.The stem and head were replaced without complications.It was reported that no further information was available.

• Brand Name: KINECTIV MODULAR NECK P 12/14 NECK TAPER USE WITH +0 HEADS ONLY
• Common Device Name: PROSTHESIS, 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: 20835906
• Report Number: 0001822565-2024-03807
• Device Sequence Number: 12918602
• Product Code: LPH
• UDI-Device Identifier: 00889024137820
• UDI-Public: (01)00889024137820(17)331114(10)66285602
• 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: 2024
• Device Explanted Year: 2024
• 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): 12/02/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00784801300
• Device Lot Number: 66285602
• 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: 11/25/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 81 KG