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

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: canada.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.Additional associated products: 00585001296, polyethylene insert xt size b, lot#: 64810777.00588000500, tibial component precoat size 5, lot#: 64739923.
Event or Problem Description
It was reported that x-ray showed that the segmental hinge pin and cap were out approximately 4 months after the implantation.This created instability and had to be revised.The revision went well.
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.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.The femoral and polyethylene insert are compatible.However the complete construct compatibility could not be assessed due to insufficient information.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the cap of the hinge pin has separated from the pin and there is slight lateral position of the pin.There is no fracture or dislocation.Implant fit and overall alignment is maintained.Complaint is 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.

• 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: 15502442
• Report Number: 0001822565-2022-02826
• Device Sequence Number: 5286541
• Product Code: KRO
• UDI-Device Identifier: 00889024195929
• UDI-Public: (01)00889024195929(17)310301(10)64980494
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585004201
• Device Lot Number: 64980494
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 70 KG