MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL FEMORAL XT COMPONENT SIZE B LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Pain (1994); Cancer (3262); Swelling/ Edema (4577)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately one year and seven months post implantation due to pain, swelling, and instability.Noted during the revision implant fracture, metal debris, and inflammatory tissue.The femur, hinge mechanism and stem exchanged with unknown products without complications.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-02234, 0001822565-2023-00097.Medical product: femoral hinge service kit xt size b item# 00585007112 lot# unknown.Articular surface with segmental hinge post size b 12 mm height item# 00585002012 lot# unknown.Report source- united kingdom.Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the provided pictures identified explanted femur, hinge, and articular surface.The hinge was broken in the picture.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: hinge post was fractured, exchanged femur, hinge mechanism and poly, there was a tumor with posterior bulge towards the vessels, knee reconstruction was complete, stable rom, with good tracking, lots of inflammatory tissue excised.Two drains were placed as well as wound vac for five to six days, patient claims instability occurred prior to falls.Hinge mechanism snapped and poly shield broken down due to metal debris.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: mechanical (g04) - femur.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned product found it to exhibit signs of being implanted nicked /gouged / scratched.Medical records were sent and previously reviewed.This review remains unchanged.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is received 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: DISTAL FEMORAL XT COMPONENT SIZE B LEFT
• 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: 16130606
• Report Number: 0001822565-2023-00096
• Device Sequence Number: 11560404
• Product Code: KRO
• UDI-Device Identifier: 00889024195929
• UDI-Public: (01)00889024195929(17)301025(10)64892037
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150028
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585004201
• Device Lot Number: 64892037
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 01/26/2023; 05/26/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 01/27/2023; 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown