MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLUTED STEM EXTENSION STRAIGHT PRECOAT 12 MM DIAMETER 190 MM LENGTH; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03061.Concomitant medical devices: distal femoral xt component size c left catalog#: 00585004301 lot#: 64287562, trabecular metal tibial cone, large 55x36mm left catalog#: 00545001355 lot#: 63205340, trabecular metal femoral diaphyseal cone, 30mm, small, left catalog#: 00545001730 lot#: 64308845, trabecular metal femoral diaphyseal cone, 30mm, large, left catalog#: 00545001930 lot#: 63024027, segment with male/female taper 35 mm length catalog#: 00585004635 lot#: 64236816, articular surface with segmental hinge post size c 12 mm height catalog#: 00585003012 lot#: 64345180, polyethylene insert xt size c use with distal femoral xt size c use with xt only catalog#: 00585001396 lot#: 64420837, smooth stem collar 30 mm o.D.For use with 16 mm or smaller diameter segmental stems catalog#: 00585204209 lot#: 63929518, tibial component precoat size 3 catalog#: 00588000300 lot#: 64227455, stem extension straight 15mm dia x 30mm length(combined length 75mm) catalog#: 00598801215 lot#: 64199746.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient is experiencing femoral loosening approximately nine months post-implantation.A revision procedure has been scheduled.Attempts have been made and no further information has been provided.
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.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: five views of the left thigh and knee demonstrate a left total knee arthroplasty with hinged prosthesis and long stem femoral component.Distal femoral resection with long stem left total knee arthroplasty.No definite evidence for loosening but there is rotation of the femur with respect to the tibial component.Ossific density involving the distal aspect of the left femur laterally is presumably postsurgical.No significant radiolucency.Suggestion of a large joint effusion.Rotation of the femoral component with respect to the tibial component without definite evidence for loosening suggesting malposition.Distal femoral resection is present.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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.
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 corrected and additional information.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FLUTED STEM EXTENSION STRAIGHT PRECOAT 12 MM DIAMETER 190 MM LENGTH
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10459692
• Report Number: 0001822565-2020-03060
• Device Sequence Number: 19369867
• Product Code: KRO
• UDI-Device Identifier: 00889024197848
• UDI-Public: (01)00889024197848(17)290430(10)64287758
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K070978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/16/2021

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: 00585205212
• Device Lot Number: 64287758
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 11/11/2020; 12/28/2020; 02/12/2021
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 11/17/2020; 01/20/2021; 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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