MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 13.5; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a right total hip arthroplasty.Subsequently, the patient fell going down stairs and sustained a periprosthetic fracture.The patient underwent an open reduction of the fracture, with cerclage cables, along with a revision of the right hip approximately 1.5 months later.The acetabular component remained well fixed and all other components were revised.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: ref 30123606 lot 64594615 liner- g7 vivacet-e highly crosslinked, size 36 id, high wall; ref 00877503604 lot 2964399 biolox ceramic head size 37, +7 (winterthur); ref 110010246 lot 65300634 biomet g7 acetabular shell with cluster holes size 56; ref 00625006540 lot j6710215 bone screw 6.5mm x 40 self-tapping ; ref 00625006535 lot j7245457 bone screw 6.5x35 self tapping.(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient fell going down the stairs and underwent a revision the same day.Cables were placed to reduce the fracture.The stem, head and liner were replaced with zimmer products.Review of the device history record identified no deviations or anomalies during manufacturing.It was reported the patient fell down the stairs and sustained a periprosthetic fracture.However, as the reason for the fall is unknown, 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: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 13.5
• 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: 15335618
• Report Number: 0001822565-2022-02524
• Device Sequence Number: 17763886
• Product Code: LPH
• UDI-Device Identifier: 00889024131910
• UDI-Public: (01)00889024131910(17)281031(10)63989036
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K192660
• 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): 08/31/2022

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: 00771101320
• Device Lot Number: 63989036
• 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: 08/16/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2018
• 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: Male
• Patient Weight: 67 KG