MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION D RIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that 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.
Event or Problem Description
It was reported a customer received a rhk.Approximately 3 years post implantation the hinge was noted as fractured, identified by x-ray.Dr.(b)(6) removed the hinge and replaced it.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Additional associated products & mdrs: (b)(4) tibial component precoat size 3 lot# 64507273, (b)(4) articular surface w/hinge post ext screw size d 12 mm ht lot# 64142752, (b)(4) all poly patella cemented 32 mm diameter lot# 64485705, (b)(4) stem extension straight 12.7 mm dia.X 30 mm length lot# 64095192, (b)(4) stem extension cemented 13 mm dia.X 60 mm length lot# 64263983.
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.Additional associated products and mdrs: 00588004012 articular surface w/hinge post ext screw size d 12 mm ht lot#: 64142752 mdr: 0001822565-2022-02285.
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.Visual examination of returned item found signs of being implanted (gouged / nicked / wear) and the hinge post extension has striations on the shaft/ damage to the threads and the thread feature has fractured off.Visual examination of the returned hinge post found damage to the threads and a section of the threaded feature has fractured off.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The hinge post was submitted for further analysis.Analysis found fatigue striations, suggesting the fatigue failure mode.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.X-rays were provided however they were not sent for further evaluation as it would not enhance the investigation.This complaint was confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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
No further event information available at the time of this report.

• Brand Name: FEMORAL COMPONENT OPTION D RIGHT
• Common Device Name: PROSTHESIS, KNEE
• 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: 14573446
• Report Number: 0001822565-2022-01651
• Device Sequence Number: 14910816
• Product Code: KRO
• UDI-Device Identifier: 00889024199132
• UDI-Public: (01)00889024199132(17)250131(10)64442226
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K013385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/23/2022
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00588001402
• Device Lot Number: 64442226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/08/2022
• Supplement Date Received by Manufacturer: 06/07/2022; 07/12/2022; 08/17/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 07/06/2022; 08/03/2022; 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown